MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 1 LEVEL ACP SIZE 14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48651114
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a reflex hybrid 2 plate locking mechanism the locking ring came out of the plate.Surgery was successfully completed with a 3 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection confirmed that one of the locking rings disengaged from the plate as reported.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It was reported that the implantation angle was not difficult, no complex maneuver nor excessive force was used, the screw was self drilling and no tools were used to prepare screw hole, all in one guide was not used, the customer did not report bending the plate, bone quality is unknown.The root cause of the reported event is most likely not using all in one guide during screw insertion.Per the stg to ensure proper locking of the bone screws, freehand insertion of the bone screws is not recommend.The all-in-one guide is strongly recommended when self-drilling screws are used.Potential contributing factors based on the risk file: - incorrect screw and/or screw hole trajectory - insufficient visibility - screw over angulated - screw does not immediately cut into bone and causes force to act on locking ring.
Event or Problem Description
It was reported that the locking ring of a reflex hybrid 2 plate disengaged from the plate intra-operatively.The procedure was completed successfully with a 3 minute surgical delay.No adverse consequences or medical intervention were reported.

• Brand Name: REFLEX-HYBRID 1 LEVEL ACP SIZE 14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 12037233
• Report Number: 0009617544-2021-00110
• Device Sequence Number: 1492615
• Product Code: KWQ
• UDI-Device Identifier: 04546540534729
• UDI-Public: 04546540534729
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/27/2021

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: 48651114
• Device Catalogue Number: 48651114
• Device Lot Number: 208498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1