MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C 7 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	48321074
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, an x-ray indicated that the screw advanced beyond the implant.The entire construct (2 screws, 1 cage) were removed and replaced with a cage and a plate.Upon removal the cage came apart.All fragments were retrieved.There was a reported 20 minute surgical delay.No reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The device was not returned for evaluation as it was kept at the hospital.Therefore functional, visual and dimensional inspections could not be performed.The lot number was not provided therefore device history review and complaint history review could not be performed.It was reported that the inserter was used during the procedure.The screw holes were prepared with an awl.It did not seem that the screw holes were implanted at difficult angle nor that excessive force was used when implanting the screw.Patient¿s bone quality was good.No x-rays or patient information is available.No further investigation for this event is possible at this time as no devices nor x-rays of the reported event were received.Potential causes may be user applying to much force during cage removal which may have caused disengagement of cage components.
Event or Problem Description
It was reported that during surgery, an x-ray indicated that the screw advanced beyond the implant.The entire construct (2 screws, 1 cage) were removed and replaced with a cage and a plate.Upon removal the cage came apart.All fragments were retrieved.There was a reported 20 minute surgical delay.No reports of adverse consequences to the patient.

• Brand Name: ANCHOR C 7 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7493379
• Report Number: 3005525032-2018-00032
• Device Sequence Number: 122396
• Product Code: OVE
• UDI-Device Identifier: 04546540679369
• UDI-Public: (01)04546540679369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 48321074
• Device Catalogue Number: 48321074
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1