MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF TAPPING 10MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48325310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while placing a screw into the cage, the screw stopped advancing and the locking ring on the screw broke.The appropriate guide was being used.The hole for the screw had been prepared with both an awl and drill.
Additional Manufacturer Narrative
Method: risk assessment.Results: the reported product was not returned and therefore unable to confirm the reported event.Conclusion: the root cause cannot be determined as the product was not returned for evaluation and no lot number was provided.
Event or Problem Description
It was reported that while placing a screw into the cage, the screw stopped advancing and the locking ring on the screw broke.The appropriate guide was being used.The hole for the screw had been prepared with both an awl and drill.

• Brand Name: ANCHOR C DIAM.3.5MM SELF TAPPING 10MM
• 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: 5490028
• Report Number: 3005525032-2016-00025
• Device Sequence Number: 18957198
• Product Code: OVE
• UDI-Device Identifier: 04546540679758
• UDI-Public: (01)04546540679758
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 02/16/2016

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 Catalogue Number: 48325310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR