MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C 6 X 12 X 14 X 4DEG. CERVICAL STD ALONE CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48321064
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon broke the threaded obdurate inside of a 6mm implant.No adverse consequences and no surgical delay was reported.
Additional Manufacturer Narrative
No product has been returned as of yet and despite of multiple attempts no information regarding the return or this event was provided.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The root cause was not determined.
Event or Problem Description
It was reported that; surgeon broke the threaded obdurate inside of a 6mm implant.No adverse consequences and no surgical delay was reported.

• Brand Name: ANCHOR C 6 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: 5984163
• Report Number: 3005525032-2016-00119
• Device Sequence Number: 79373
• Product Code: OVE
• UDI-Device Identifier: 04546540679338
• UDI-Public: (01)04546540679338
• 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): 08/29/2016

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: 48321064
• Device Lot Number: B44150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1