MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48554308
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; occipital plate broke and replaced with the 100 degree occipital plate and extension of screws from c7 down to t4.
Additional Manufacturer Narrative
Method: risk assessment; result: the reported event was confirmed via correspondence with the sales representative.The reported event resulted in a revision surgery to remove the fractured construct and replace it with a new construct.It was reported that there were no complications during the initial surgery, the bone quality was good and that the patient did not experience a fall.An x-ray of the initial implantation was provided and no anomalies were observed.Manufacturing files were not reviewed due to no parts or lot provided.The device has not been returned for evaluation.The root cause of the reported event could not be determined.
Event or Problem Description
It was reported that; occipital plate broke and replaced with the 100 degree occipital plate and extension of screws from c7 down to t4.

• Brand Name: OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7052223
• Report Number: 0009617544-2017-00419
• Device Sequence Number: 11084597
• Product Code: KWP
• UDI-Device Identifier: 04546540371911
• UDI-Public: (01)04546540371911
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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 Model Number: 48554308
• Device Catalogue Number: 48551045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 03/09/2018
• 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
• Patient Weight: 82