MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS AL SPACER 8 X 22 X 28 X 4 DEG.; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48326084
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while surgeon was impacting the graft it fractured at the point where the inserter holds the graft.The loose pieces were removed.The surgeon attempted to remove the posterior part of the graft but was unable to.Due to the tight fit of the graft it was decided to leave the posterior portion.
Additional Manufacturer Narrative
Method: risk assesment.Result: the reported event of spacer main body fracture intra-op was confirmed via email correspondence with the stryker sales rep.The product was not returned.Conclusion: the probable root cause of this event is impaction force applied to the graft during the insertion.
Event or Problem Description
It was reported that while surgeon was impacting the graft it fractured at the point where the inserter holds the graft.The loose pieces were removed.The surgeon attempted to remove the posterior part of the graft but was unable to.Due to the tight fit of the graft it was decided to leave the posterior portion.

• Brand Name: AVS AL SPACER 8 X 22 X 28 X 4 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: 5613103
• Report Number: 0009617544-2016-00168
• Device Sequence Number: 2478
• Product Code: MAX
• UDI-Device Identifier: 07613252160212
• UDI-Public: (01)07613252160212
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2016

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: 48326084
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2016
• Supplement Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 46