MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF TAP.SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48694014
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that approximately 7 years post-operatively it was noticed via x-ray that a reflex-hybrid variable angle self tap bone screw had fractured and migrated.The patient reported pain.
Additional Manufacturer Narrative
Device remains implanted.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that approximately 7 years post-operatively it was noticed via x-ray that a reflex-hybrid variable angle self tap bone screw had fractured and migrated.The patient reported pain.

• Brand Name: REFLEX-HYBRID 4X14MM 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
• 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: 16598292
• Report Number: 0009617544-2023-00010
• Device Sequence Number: 19947789
• Product Code: KWQ
• UDI-Device Identifier: 04546540535108
• UDI-Public: 04546540535108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 48694014
• Device Catalogue Number: 48694014
• Device Lot Number: CEK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2013
• 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