MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 1 LEVEL ACP SIZE 18MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48651118
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during screw insertion, the gold locking ring of a reflex hybrid 1 level plate separated from the plate.The screw and locking ring were removed and a new screw was inserted.The plate was left in the patient without the fourth locking ring which had separated from the plate.There were no adverse consequences to the patient or reported surgical delays.
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that during screw insertion, the gold locking ring of a reflex hybrid 1 level plate separated from the plate.The screw and locking ring were removed and a new screw was inserted.The plate was left in the patient without the fourth locking ring which had separated from the plate.There were no adverse consequences to the patient or reported surgical delays.
Additional Manufacturer Narrative
Microscopic inspection was performed on the locking ring.Material abrasion and discoloration was identified on the surface and edges of the ring.The spiral shape of the ring among with the material abrasion indicate that the screw did not follow appropriate pathway and/or was inserted below the locking ring and damaged the ring.Per the surgical technique "screws should be inserted to the point where they are just above the ring".Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported that the ring fractured off before final tightening.The reflex ug screw extractor assembly and the reflex ug screw extractor inner shaft were used to insert the screw.The drill guide was not used, the implantation angle is unknown, the customer did not report bending the plate, bone quality is unknown.The root cause of the ring disengagement is most likely incorrect trajectory due to free-handing during hole preparation among with a wrong device used to insert the screw.Per the surgical technique, the screw extractor is the primary instrument used to remove bone screws that have been locked into the plate.Bone screws should be placed using one of three insertion drivers: the quick turn screwdriver, the collet screwdriver or the insertion driver.In addition, potential contributing factors based on the risk file: insufficient visibility.Screw over angulated.Screw does not immediately cut into bone and causes force to act on locking ring.

• Brand Name: REFLEX-HYBRID 1 LEVEL ACP SIZE 18MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13446824
• Report Number: 0009617544-2022-00009
• Device Sequence Number: 4321756
• Product Code: KWQ
• UDI-Device Identifier: 04546540534743
• UDI-Public: 04546540534743
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/14/2022

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 Model Number: 48651118
• Device Catalogue Number: 48651118
• Device Lot Number: 198884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown