STRYKER EVANS WEDGE
Received Nov 12, 2020 · Event occurred Nov 4, 2020
Report MW5097863 · MDR key 10837693
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
AllosourceModel number
NACatalog number
3102-1910
Lot number
NA
Product problems
- Manufacturing, Packaging or Shipping Problem
Patient
23 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IMPLANT IDENTIFIED ON THE SEALED PACKAGE OF THE EVANS WEDGE MANUFACTURED BY ALLOSOURCE, DISTRIBUTED BY (B)(4) WAS # (B)(4). THE INTERNAL SEALED PACKAGE WITHIN THE GRAFT WAS LABELED WITH A DIFFERENT UNIQUE IDENTIFIER, ID# (B)(4). THE GRAFT WAS AN EVANS WEDGE, AS DESCRIBED, BUT HAD DIFFERENT MEASUREMENTS THAN ON THE OUTSIDE PACKAGING. . THE GRAFT'S ACTUAL MEASUREMENT AS DESCRIBED IN THE INTERNAL PACKAGING WAS 10X22X20MM. PHYSICIAN AND NURSE ACKNOWLEDGED THE DISCREPANCY WITH A INTERNAL VARIANCE. SINCE THE INTERNAL PACKAGING WAS INTACT AND NOT COMPROMISED, THE SURGEON IMPLANTED THE GRAFT.