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

Catalog Number 48651116

Device Problems Material Protrusion/Extrusion (2979); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event 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.

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 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
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8765017
• MDR Text Key: 150370414
• Report Number: 0009617544-2019-00085
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 04546540534736
• UDI-Public: 04546540534736
• Combination Product (y/n): N
• PMA/PMN Number: K063430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48651116
• Device Lot Number: 177053
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1