MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LUMBAR STAND ALONE- CAGE 10 X 22 X 30 MM X 4 DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48662104
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the implant cracked.
Additional Manufacturer Narrative
Method: risk assessment.Results: device inspection, device history review and complaint history review could not be performed since the device was not returned (still implanted).Conclusion: the most likely cause of the reported event was determined to be misuse, specifically the user did not use the guide instrument when inserting the screws.
Event or Problem Description
It was reported that: the implant cracked.

• Brand Name: ANCHOR L LUMBAR STAND ALONE- CAGE 10 X 22 X 30 MM X 4 DEG
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5574745
• Report Number: 3005525032-2016-00038
• Device Sequence Number: 965772
• Product Code: MAX
• UDI-Device Identifier: 07613252601913
• UDI-Public: (01)07613252601913
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2016

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: 48662104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 06/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1