MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL LUMBAR CAGE 26 X 32MM, 11MM, 08 DEG.; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48922618
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/18/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor noticed on post op x ray that the anchor was backing out.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assesment result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Based on the sales rep's description of "the surgeon didn't double check if the anchor was locked after its insertion.It seemed like that the anchor tamps were bottomed out during insertion, but it is possible that one was not fully bottomed out." conclusion: the most likely cause of the reported event was determined to be user related.
Event or Problem Description
It was reported that the doctor noticed on post op x ray that the anchor was backing out.

• Brand Name: AERO AL LUMBAR CAGE 26 X 32MM, 11MM, 08 DEG.
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5721522
• Report Number: 0009617544-2016-00233
• Device Sequence Number: 16143560
• Product Code: OVD
• UDI-Device Identifier: 07613327067699
• UDI-Public: (01)07613327067699
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48922618
• Device Lot Number: 145782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR