MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 4 LEVEL ACP SIZE 72MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 48651472

Device Problems Fracture (1260); Material Deformation (2976)

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 four-level reflex-hybrid plate.

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 four-level reflex-hybrid plate.

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 four-level reflex-hybrid plate.

Manufacturer Narrative

Visual: visual inspection confirmed that the locking mechanism on the plate was deformed.The locking ring was deformed so that the ring was protruding toward the anterior side of the plate.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Sgt was reviewed and the following was found relevant: bending the plate in a vicinity of a screw hole must be avoided as it may compromise the locking ring mechanism.Due to the notch sensitivity of titanium, the plate should never be reverted to its original shape once it has been contoured.Bone screws can be placed using one of three insertion drivers: the quick turn screwdriver, the collet screwdriver or the insertion driver.To avoid damage to the screwdriver, the final tightener must be used to lock the screws in the ring.Screws should be inserted to the point where they are just above the ring.Inserting the screws sequentially at opposite corners of the plate ¿ and working toward the center of the plate ¿ helps keep the plate flat against the bone.Once all bone screws have been inserted, the final tightening screwdriver should be used to lock the screws into the ring.The final tightening screw-driver features a protruding center pin to facilitate placement into the screw head.To facilitate identification, the shaft of the final tightening screwdriver has been anodized gold note: the amount of torque required to complete final tightening can be done with a single hand, and should not exceed one quarter turn once the screw is underneath the ring.In addition to the tactile sensation of the locking ring closing over the bone screw head, final screw locking should also be confirmed visually with the ring being clearly visible over the bone screw head.It is possible that the entire ring may not be visible if the screws have been implanted at their extreme angulation; however, two-thirds of the ring is designed to provide sufficient coverage for safe locking of the bone screw to the plate.The root cause of the reported event cannot be determined conclusively from the information provided or returned product.Locking ring deformation was likely altered during screw removal.Potential root causes include misalignment of screw threading, hard bone quality, and/or excessive force applied during insertion.

• Brand Name: REFLEX-HYBRID 4 LEVEL ACP SIZE 72MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11791137
• MDR Text Key: 249492346
• Report Number: 0009617544-2021-00076
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 04546540535016
• UDI-Public: 04546540535016
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48651472
• Device Catalogue Number: 48651472
• Device Lot Number: 190965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 05/17/2021; 08/06/2021
• Supplement Dates FDA Received: 06/15/2021; 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1