MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL LUMBAR CAGE 22 X 28MM, 11MM, 08 DEG.; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48922218
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the case the bottom left anchor got stuck in the inserter and would not advance into the bone and deformed significantly.Osteophytes were present and the pilot cutter was used.The cutter tip was visibly damaged.It was incredibly difficult to unthread the inside shaft to remove the inserter from the cage.The damaged anchor was retrieved and the case was completed with 3 anchors implanted.
Additional Manufacturer Narrative
Catalog# 48922218.Method: visual inspection; device history review; complaint history review; risk assessment results: the returned device was confirmed to be deformed upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the plausible root cause is likely due to the hard bone quality of the patient.
Event or Problem Description
It was reported that during the case the bottom left anchor got stuck in the inserter and would not advance into the bone and deformed significantly.Osteophytes were present and the pilot cutter was used.The cutter tip was visibly damaged.It was incredibly difficult to unthread the inside shaft to remove the inserter from the cage.The damaged anchor was retrieved and the case was completed with 3 anchors implanted.

• Brand Name: AERO AL LUMBAR CAGE 22 X 28MM, 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: 5439393
• Report Number: 0009617544-2016-00061
• Device Sequence Number: 1135300
• Product Code: OVD
• UDI-Device Identifier: 07613327065572
• UDI-Public: 07613327065572
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2016

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: 48922218
• Device Lot Number: 145766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2016
• Supplement Report FDA Received Date: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1