MAUDE Adverse Event Report: ALLOSOURCE STRYKER EVANS WEDGE; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Catalog Number 3102-1910

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

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.

• Brand Name: STRYKER EVANS WEDGE
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): ALLOSOURCE ; 6278 south troy circle ; centennial CO 80111
• MDR Report Key: 10837693
• MDR Text Key: 216416769
• Report Number: MW5097863
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 1705651026
• UDI-Public: 1705651026
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Catalogue Number: 3102-1910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR