Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 3 LEVEL ACP SIZE 54MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER SPINE-US REFLEX-HYBRID 3 LEVEL ACP SIZE 54MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Model Number 48651354
Device Problems Bent (1059); Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2018
Event Type  malfunction  
Event Description
It was reported that the surgeon noticed that the ring on the plate bent, opened up, and came detached from the plate itself.The screw was aborted and the surgeon proceeded with the procedure without using that hole for fixation.There are no reports of adverse health consequences to the patient.
 
Manufacturer Narrative
Method: visual inspection, labelling review, risk assessment.Conclusion: the reported locking ring disengagement was confirmed upon email correspondence with the sales representative.The ring that disengaged was returned, however the plate was left implanted and the screw was discarded.Lot number was not provided and could not be retrieved from the returned ring.Therefore, device history review and complaint history review could not be performed.Per email correspondence with the sales rep, the screw holes were not prepared.Self drilling screws were used and threaded in.The locking mechanism broke prior to final tightening.Bone quality of the patient is normal according to the surgeon.The device surgical technique states: "note: to ensure proper locking of the bone screws, freehand insertion of the bone screws is not recommended and can result in back-out of bone screws if not properly aligned." incorrect screw trajectory can cause the screw to force ring to disengage from plate.It is likely that the ring disengaged due to incorrect trajectory, however, without device evaluation of the screw and/or the plate, the root cause could not be determined conclusively.
 
Event Description
It was reported that the surgeon noticed that the ring on the plate bent, opened up, and came detached from the plate itself.The screw was aborted and the surgeon proceeded with the procedure without using that hole for fixation.There are no reports of adverse health consequences to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REFLEX-HYBRID 3 LEVEL ACP SIZE 54MM
Type of Device
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7423449
MDR Text Key105517323
Report Number0009617544-2018-00081
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier04546540534927
UDI-Public(01)04546540534927
Combination Product (y/n)N
PMA/PMN Number
K063430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48651354
Device Catalogue Number48651354
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2018
Date Manufacturer Received06/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-