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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 6430530
Device Problem Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a health care provider via a manufacturer representative regarding a mas extender tab and set screw used for spinal therapy. Pre-operative diagnosis was lumbar spinal canal stenosis. Levels implanted was l4/5. Procedure performed was mis-tlif. It was reported that intra-operatively, the reported product was used with the l4 right pedicle screw. At the time of final tightening, the set screw did not break off and idled. Even though the set screw was replaced, it did not improve, so the reported product had been replaced. The final tightening could not be performed when fixing at one intervertebral disc with voyager 4. 75. After the final tightening of the l5 right set screw, the l4 right set screw idled and could not be finally tightened. After replacing the screw at the right side of l4, the final tightening was completed without any problem, and the operation had been completed. The compressor was not used, and the counter torque had been used. Only the set screw that could not be finally tightened for the first time and the screw that was replaced were scheduled to be returned. The set screw behaved like idling inside when a torque that should break off the set screw by right was applied. The screw was replaced and the new one has been broken off as usual with the same driver, so there was no problem with the set screwdriver. The products were in contact with patient and has been confirmed that there are no infectious diseases. There was a possibility that the screw head or tab became widened because the set screw idled and could not be finally tightened, and when the screw was replaced with a substitute one, the final tightening could be performed as usual. There was a delay of less than 60 min in overall procedure time. There was no in-patient hospitalization or prolongation of existing hospitalization necessary. There were no patient symptoms or complications as a result of this event. There was no treatment or additional surgery performed as a result of this event.

 
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Brand NameCD HORIZON SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key12025890
MDR Text Key258717951
Report Number1030489-2021-00806
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK143375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/18/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6430530
Device Catalogue Number6430530
Device LOT Number0785191W
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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