MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF DRILLING 12MM; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48335312
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that screw backed out, 4months post op.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Some deformities were found under the locking clip and on the top of the screw.Manufacturing review was performed and no anomalies were identified.The plausible root cause cannot be determined based on the information provided.
Event or Problem Description
It was reported that screw backed out, 4 months post op.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 12MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6478086
• Report Number: 3005525032-2017-00045
• Device Sequence Number: 19132214
• Product Code: OVE
• UDI-Device Identifier: 04546540679840
• UDI-Public: (01)04546540679840
• Combination Product (Y/N): N
• 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): 06/22/2017

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: No Information
• Device Catalogue Number: 48335312
• Device Lot Number: CDT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 06/22/2017
• 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