MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 22 X 30 MM X 8 DEG; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	48662128
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The inserter came off of the cage and the cage broke upon insertion.The issue was resolved upon re-insertion of the same size cage on the same inserter and all in one guide.There was a reported 4-5 minutes of operating room time to get all fragments out of interspace.There are no reports of adverse health consequences.
Additional Manufacturer Narrative
Method: risk assessment; result: the reported event could not be confirmed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The sales rep reported that the surgeon did not tighten the cage perfectly with locking set screw on the all in one guide because of which the cage came off and it broke.Conclusion: the most likely cause of the reported event was determined to be user error.
Event or Problem Description
The inserter came off of the cage and the cage broke upon insertion.The issue was resolved upon re-insertion of the same size cage on the same inserter and all in one guide.There was a reported 4-5 minutes of operating room time to get all fragments out of interspace.There are no reports of adverse health consequences.

• Brand Name: ANCHOR L LUMBAR STAND ALONE- CAGE 12 X 22 X 30 MM X 8 DEG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 7266761
• Report Number: 3005525032-2018-00006
• Device Sequence Number: 13788893
• Product Code: OVD
• UDI-Device Identifier: 07613252601968
• UDI-Public: (01)07613252601968
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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 Model Number: 48662128
• Device Catalogue Number: 48662128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1