MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C DIAM 3.5MM SELF DRILLING 12MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	48335312
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an anchor c self drilling screw at c5 backed out of a cage post-operatively.Revision surgery has occurred where the screw was replaced and the cage was re-implanted.
Event or Problem Description
It was reported that an anchor c self drilling screw at c5 backed out of a cage post-operatively.Revision surgery has occurred where the screw was replaced and the cage was re-implanted.
Additional Manufacturer Narrative
Visual: locking ring is intact.No deformation/fracture was identified.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per the stg: excessive pivoting or angulation of the screwdriver while attached to the screw should be avoided as it can cause damage to the screwdriver and/or screw.Note: to ensure proper depth and adequate locking when using the awl, drilling, or locking bone screws, use of a free hand technique is strongly discouraged.Use of the guide/inserter tip or low profile inserter is required.The inserter may separate slightly from the cage throughout the procedure.A gap between the cage and inserter may result in improper seating of the screw.Prior to screw insertion, ensure the inserter is flush to the cage.Screw is locked when the gold color and the black line are no longer visible.The root causes of the screw migration could not be determined conclusively based on the information provided.Most likely the screw was not properly inserted/locked during the initial surgery and caused the screw to migrate one day post-op.Per anchor c risk file, migration may occur due to: -screw was not properly inserted/locked into the implant (due to not using the inserter throughout the entire procedure, overtightening the screw, implanting the screw at difficult angle).-poor patients bone quality.-patient experiences sudden impact.

• Brand Name: ANCHOR C DIAM 3.5MM SELF DRILLING 12MM
• 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: 11499194
• Report Number: 3005525032-2021-00010
• Device Sequence Number: 4101713
• Product Code: OVE
• UDI-Device Identifier: 04546540679840
• UDI-Public: 04546540679840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48335312
• Device Catalogue Number: 6741612
• Device Lot Number: ZX8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention