MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR L LUMBAR STAND ALONE- CAGE 10 X 22 X 30 MM X 8 DEG; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	48662108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage cracked while the surgeon was lagging the third and final screw.The cage was left implanted in the patient.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence with the sales representative.The cage was not returned for evaluation nor the lot number was provided therefore device inspection, complaint history review and device history review cannot be performed.Due to the device not being returned, a definite root cause cannot be determined.According to the risk file, cage breakage may be caused by: user applies cantilever force on screwdriver while inserting the screw, previously deformed of damaged screwdriver used, screw hole inadequately prepared, excessive torsional/axial force applied by the user.
Event or Problem Description
It was reported that the cage cracked while the surgeon was lagging the third and final screw.The cage was left implanted in the patient.There are no reports of adverse health consequences to the patient.

• Brand Name: ANCHOR L LUMBAR STAND ALONE- CAGE 10 X 22 X 30 MM X 8 DEG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7379295
• Report Number: 3005525032-2018-00012
• Device Sequence Number: 1233550
• Product Code: OVD
• UDI-Device Identifier: 07613252601920
• UDI-Public: (01)07613252601920
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/22/2018

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: 48662108
• Device Catalogue Number: 48662108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1