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

Catalog Number	48335310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw would not advance below the locking mechanism of the implant.The locking ring on top of the screw appeared to be distorted.Another size screw was used to complete the surgery.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the anchor c surgical technique states that use of a free hand technique is strongly discouraged and use of the guide/inserter tip is required.Conclusion: the established cause of the event is multifactorial; general user error.
Event or Problem Description
It was reported that the screw would not advance below the locking mechanism of the implant.The locking ring on top of the screw appeared to be distorted.Another size screw was used to complete the surgery.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 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: 5496138
• Report Number: 3005525032-2016-00027
• Device Sequence Number: 10847858
• Product Code: OVE
• UDI-Device Identifier: 04546540679833
• UDI-Public: (01)04546540679833
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/17/2016

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: 48335310
• Device Lot Number: FSZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2016
• 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: 68 YR