MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C 7 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48321074
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon had difficulty removing screws from cage.Update (b)(6) 2017 the plate of the cage broke off.Everything was retrieved.
Additional Manufacturer Narrative
Lot# b63360; visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The event was confirmed via visual inspection of the returned device.The cage was returned in 2 pieces.The plausible root cause of the reported event is most likely user error, specifically application of extensive/off axis force.
Event or Problem Description
It was reported that; surgeon had difficulty removing screws from cage.Update (b)(6) 2017 the plate of the cage broke off.Everything was retrieved.

• Brand Name: ANCHOR C 7 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE
• 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: 6445576
• Report Number: 3005525032-2017-00043
• Device Sequence Number: 588049
• Product Code: OVE
• UDI-Device Identifier: 04546540679369
• UDI-Public: (01)04546540679369
• 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): 06/15/2017

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: 48321074
• Device Lot Number: B63360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1