MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 4X16MM VARIABLE ANGLE SELF TAP.SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48694016
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an anterior cervical pressure fixation surgery for c3-6 was performed on (b)(6) 2018.On (b)(6) 2018, post operative x-ray indicated that the screw came out of the plate.Since there are no subjective symptoms such as uncomfortable feeling in the patient, the patient is under observation.
Additional Manufacturer Narrative
Method: risk assessment, x-rays.Results: the event was confirmed via provided x-rays.Visual, dimensional and functional analysis could not be performed as the device was not returned, it remains implanted.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the exact root cause of this event cannot be determined conclusively.The possible root causes may be: excessive axial/torsional force applied during screw insertion.Over angulation of screw during insertion.Screw driven too deep.
Event or Problem Description
It was reported that an anterior cervical pressure fixation surgery for c3-6 was performed on (b)(6) 2018.On (b)(6) 2018, post operative x-ray indicated that the screw came out of the plate.Since there are no subjective symptoms such as uncomfortable feeling in the patient, the patient is under observation.

• Brand Name: REFLEX-HYBRID 4X16MM VARIABLE ANGLE SELF TAP.SCREW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7667676
• Report Number: 0009617544-2018-00166
• Device Sequence Number: 1528475
• Product Code: KWQ
• UDI-Device Identifier: 04546540535115
• UDI-Public: (01)04546540535115
• Combination Product (Y/N): N
• PMA/510(K) Number: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2018

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: 48694016
• Device Catalogue Number: 48694016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 09/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR