Device product
90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Z-1535-2013
Product summary
- Event
- Event 65091
- Status
- Terminated
- Classification
- Class II
- Quantity
- 130 devices were shipped
- Official record key
device-enforcement:Z-1535-2013
Official wording
Reason: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Code information: All lot numbers are affected. Catalog No. 00-1200-1001
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Unknown
Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.