MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 1 LEVEL ACP SIZE 16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48651116
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that during c5/c6 fixation , the locking ring of the plate was visible before the screw was implanted and locking could not be confirmed.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Visual, functional, dimensional, and material analyses could not be performed because the device remains implanted.A review of product history found no manufacturing issues and a review of complaint history identified no similar complaints for the reported lot number.Additional information was requested but not provided.The reflex-hybrid surgical technique states: "the screw extractor is the primary instrument used to remove bone screws that have been locked into the plate.While the larger tip of the screwdriver spreads the locking ring, the threaded inner shaft allows for rigid attachment of the screw to the screwdriver.In addition, the instrument utilizes an outer sleeve to provide counter force against the plate during screw removal." "the locking mechanism of the reflex® hybrid acp system has been tested to ensure that a screw inserted into a previously used screw hole will be securely locked*.The locking ring can be re-used for the implantation of a rescue screw.However, repeated screw insertion through the locking ring should be avoided as its function may have been compromised.A maximum of two bone screw insertions is recommended for any screw hole within a plate." as the device could not be evaluated and no additional information was provided by the reporter, it is not possible to determine a definitive root cause.Possible root causes include: insufficient visibility, hard bone quality, guide/punch awl not used to prepare screw hole, screw is not securely attached to screwdriver, screw hole too shallow, screw threads are worn/stripped, and/or plate/screw were previously used as a demo.
Event or Problem Description
It was reported that during c5/c6 fixation, the locking ring of the plate was visible before the screw was implanted and locking could not be confirmed.There are no reports of adverse consequences to the patient.

• Brand Name: REFLEX-HYBRID 1 LEVEL ACP SIZE 16MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8765017
• Report Number: 0009617544-2019-00085
• Device Sequence Number: 16654828
• Product Code: KWQ
• UDI-Device Identifier: 04546540534736
• UDI-Public: 04546540534736
• Combination Product (Y/N): N
• PMA/510(K) Number: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: Health Professional
• Device Catalogue Number: 48651116
• Device Lot Number: 177053
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1