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	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that insertion of a 4.0 mm reflex screw at left c4, "was not effective." while removing the screw, the securing mechanism of a four-level reflex hybrid plate fractured.All screws and the plate were removed and replaced.The procedure was completed successfully with no adverse consequence to the patient.This report captures the 4.0 mm reflex screw.
Event or Problem Description
A company representative reported that insertion of a 4.0 mm reflex screw at left c4 would not final lock.While removing the screw, the securing mechanism of a four-level reflex hybrid plate fractured.All screws and the plate were removed and replaced.The procedure was completed successfully with no adverse consequence to the patient.This report captures the 4.0 mm reflex screw.
Additional Manufacturer Narrative
The following fields have been updated following receipt of additional information and return of the device: b5, d9, h3.
Event or Problem Description
A company representative reported that insertion of a 4.0 mm reflex screw at left c4 would not final lock.While removing the screw, the securing mechanism of a four-level reflex hybrid plate fractured.All screws and the plate were removed and replaced.The procedure was completed successfully with no adverse consequence to the patient.This report captures the 4.0 mm reflex screw.
Additional Manufacturer Narrative
Visual: visual inspection revealed no product issue.Function: functional inspection was performed and screw was able to be attached to screw driver and inserted into plate with no issue.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Complaint history records from catalog number were reviewed for this lot, similar complaints were identified.Investigation of associated plate, mfg report # 0009617544-2021-00076, revealed that the locking mechanism deformed and most likely caused the lock to not properly close over screw.

• 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
• MDR Report Key: 11791162
• Report Number: 0009617544-2021-00077
• Device Sequence Number: 19087866
• Product Code: KWQ
• UDI-Device Identifier: 04546540535108
• UDI-Public: 04546540535108
• 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,Followup
• Report Date (Section B): 08/31/2021

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: 48694014
• Device Catalogue Number: 48694014
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 08/06/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/15/2021; 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1