MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LOCKING PLATE LUMBAR STAND ALONE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48667000
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; we were using the product for a 5/1 fusion and surgeon was unable to keep locking plate in place on multiple tries.We then resorted to other plating.
Additional Manufacturer Narrative
Visual inspection; functional inspection; device history review; complaint history review; risk assessment.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Based on the functional inspection the returned plate is fully functional.The plausible cause of the event is most likely user related.
Event or Problem Description
It was reported that; we were using the product for a 5/1 fusion and surgeon was unable to keep locking plate in place on multiple tries.We then resorted to other plating.

• Brand Name: ANCHOR L LOCKING PLATE LUMBAR STAND ALONE
• 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: 6340561
• Report Number: 3005525032-2017-00016
• Device Sequence Number: 528936
• Product Code: MAX
• UDI-Device Identifier: 07613252655732
• UDI-Public: (01)07613252655732
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2017

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: 48667000
• Device Lot Number: BS8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR