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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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STRYKER SPINE-US REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 48644014
Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2019
Event Type  Injury  
Event Description
In (b)(6) 2018 the device was implanted.On review of x-ray during a post-operative check-up, the physician noted that a locking screw was "out of its place." the patient underwent revision surgery on (b)(6) 2019 during which the dislocated locking screw was removed.No adverse consequences to the patient were reported.
 
Event Description
In (b)(6) 2018 the device was implanted.On review of x-ray during a post-operative check-up, the physician noted that a locking screw was "out of its place." the patient underwent revision surgery on (b)(6) 2019 during which the dislocated locking screw was removed.No adverse consequences to the patient were reported.
 
Manufacturer Narrative
Visual, dimensional, functional and materials analysis could not be performed as the device was discarded by the hospital.Complaint history review for similar events and device history records could not be performed as a valid lot code was not provided and could not be obtained.A screw was reported to have migrated.Patient information along with pathologies and bone quality was not made available.The possible root causes of this range from: hard bone quality; guide/punch awl not used to prepare screw hole; screw hole too shallow; screw threads are worn/stripped; guide not used during screw insertion; screw over angulated.
 
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Brand Name
REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW
Type of Device
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8516816
MDR Text Key142033114
Report Number0009617544-2019-00048
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier04546540534682
UDI-Public04546540534682
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 07/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48644014
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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