MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS PL SPACER 9 X 25 X 4 DEG - 8; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48345094
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while impacting a 9x25x4 degree 8 straight cage into l5-s1 disc space the cage broke into multiple pieces.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment results: the reported event of cage main body fracture was confirmed via visual inspection of the returned device.No manufacturing issues were found that may have contributed to the reported failure.Conclusion: according to the surgical technique, the spacer must be inserted gently and progressively.The probable root cause of this event is too much impaction force applied to insert the cage into a tight disc space.
Event or Problem Description
It was reported that while impacting a 9x25x4 degree 8 straight cage into l5-s1 disc space the cage broke into multiple pieces.

• Brand Name: AVS PL SPACER 9 X 25 X 4 DEG - 8
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5707565
• Report Number: 0009617544-2016-00221
• Device Sequence Number: 13614746
• Product Code: MAX
• UDI-Device Identifier: 07613154129379
• UDI-Public: (01)07613154129379
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050624
• 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): 05/16/2016

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: 48345094
• Device Lot Number: 75602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2016
• Supplement Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1