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

Model Number 48694014

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Event 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 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.

Manufacturer Narrative

The following fields have been updated following receipt of additional information and return of the device: b5, d9, h3.

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.

Event 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.

• Brand Name: REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF TAP.SCREW
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11791162
• MDR Text Key: 249495001
• Report Number: 0009617544-2021-00077
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 04546540535108
• UDI-Public: 04546540535108
• 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,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1