MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 4 LEVEL ACP SIZE 72MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48651472
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; an acdf c3-7 was performed.The surgeon final tightening the right c5 screw and the locking ring pushed out and stuck out from the plate.Surgeon removed the screw and pulled the locking ring from the plate out of the surgical site.
Event or Problem Description
It was reported that; an acdf c3-7 was performed.The surgeon final tightening the right c5 screw and the locking ring pushed out and stuck out from the plate.Surgeon removed the screw and pulled the locking ring from the plate out of the surgical site.
Additional Manufacturer Narrative
Method: risk assessment: result: the customer reported event was confirmed via correspondence with the sales representative.The device was not returned and a valid lot number was not provided therefore manufacturing history could not be reviewed.No harm to the patient was reported.Conclusion: due to the device not being returned, a definite root cause cannot be determined.

• Brand Name: REFLEX-HYBRID 4 LEVEL ACP SIZE 72MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7112611
• Report Number: 0009617544-2017-00434
• Device Sequence Number: 1411392
• Product Code: KWQ
• UDI-Device Identifier: 04546540535016
• UDI-Public: (01)04546540535016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063430
• 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): 02/16/2018

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 Model Number: 48651472
• Device Catalogue Number: 48651472
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1