MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LUMBAR STAND ALONE- CAGE 10 X 22 X 30 MM X 8 DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48662108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screw went through the cage.
Additional Manufacturer Narrative
Lot# b50775; visual inspection, device history review, complaint history review, material analysis; risk assessment.The reported event was confirmed based on visual inspection of the returned device.Mar concluded that the cage appears to have fractured due to applied cantilever force during screw insertion.No material or manufacturing defects were found.No anomalies were identified in the manufacturing files for the device lot that may have contributed to the reported event.The plausible root causes of this event is most likely user error specifically applying excessive force during screw insertion.
Event or Problem Description
It was reported that; screw went through the cage.

• Brand Name: ANCHOR L LUMBAR STAND ALONE- CAGE 10 X 22 X 30 MM X 8 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: 6170942
• Report Number: 3005525032-2016-00155
• Device Sequence Number: 16382323
• Product Code: MAX
• UDI-Device Identifier: 07613252601920
• UDI-Public: (01)07613252601920
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2017

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: 48662108
• Device Lot Number: B50775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1