MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL LUMBAR CAGE 30 X 38MM, 13MM, 12 DEG.; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48923032
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that metal jacket was not around cage out of package; used back up cage.After implanting the back up cage.The cage blade bent upon insertion.Cutter was used.
Additional Manufacturer Narrative
Device history review.Device not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Due to the insufficient information and the device is still implanted in the patient, the root cause could not be determined conclusively.
Event or Problem Description
It was reported that metal jacket was not around cage out of package; used back up cage.After implanting the back up cage.The cage blade bent upon insertion.Cutter was used.

• Brand Name: AERO AL LUMBAR CAGE 30 X 38MM, 13MM, 12 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: 5469747
• Report Number: 0009617544-2016-00086
• Device Sequence Number: 18910650
• Product Code: OVD
• UDI-Device Identifier: 07613327065602
• UDI-Public: 07613327065602
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2016

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: 48923032
• Device Lot Number: 145802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR