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

Catalog Number	48922618
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; anchor bent upon insertion.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was determined to be related to: (1) the patient has hard bone quality; (2) pilot cutter was not used prior to the anchor insertion, which was recommended per surgical technique.
Event or Problem Description
It was reported that; anchor bent upon insertion.

• Brand Name: AERO AL LUMBAR CAGE 26 X 32MM, 11MM, 08 DEG.
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6182995
• Report Number: 3004024955-2016-00107
• Device Sequence Number: 623374
• Product Code: OVD
• UDI-Device Identifier: 07613327067699
• UDI-Public: (01)07613327067699
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133328
• 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): 02/08/2017

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: 48922618
• Device Lot Number: 1071985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1