MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR L IMPLANT HOLDER; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48992001
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery after releasing the lever implant inserter could not be removed from implant.Implant was able to remove from the inserter by pulling side out with nerve hook.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.Manufacturing history was reviewed and no issues were identified.The definitive root cause of the event cannot be determined from the given information.
Event or Problem Description
It was reported that; during surgery after releasing the lever implant inserter could not be removed from implant.Implant was able to remove from the inserter by pulling side out with nerve hook.

• Brand Name: ANCHOR L IMPLANT HOLDER
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6800029
• Report Number: 0009617544-2017-00321
• Device Sequence Number: 13485786
• Product Code: ODP
• UDI-Device Identifier: 07613252602774
• UDI-Public: (01)07613252602774
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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
• Operator of Device: No Information
• Device Catalogue Number: 48992001
• Device Lot Number: 131777
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1