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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that an achor c self drilling screw migrated post-operatively.It was noticed via x-ray that the screw began to back out approximately 1 month post-operatively.There are no plans for revision surgery at this time.
Additional Manufacturer Narrative
Visual, functional and dimensional inspections as well as material analysis was not performed as the screw remains implanted.However, three x-ray images (1) immediate post op, (2)one month post op (3) approximately four months post-op were provided and reviewed with a medical professional.It was confirmed that one of the screws is migrating out of the cage.No other anomalies were noted.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.The root causes of the reported event cannot be determine conclusively based on information provided and without implant evaluation.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; patient participated in activities not recommended by the surgeon.
Event or Problem Description
It was reported that an achor c self drilling screw migrated post-operatively.It was noticed via x-ray that the screw began to back out approximately 1 month post-operatively.There are no plans for revision surgery at this time.

• 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: 10270879
• Report Number: 3005525032-2020-00033
• Device Sequence Number: 824554
• Product Code: OVE
• UDI-Device Identifier: 04546540679840
• UDI-Public: 04546540679840
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102606
• 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): 09/29/2020

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: Health Professional
• Device Model Number: 48335312
• Device Catalogue Number: 48335312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1