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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 6430530
Device Problems Mechanics Altered (2984); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluation summary: the tip of set screws were deformed, and the threads were damaged. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a healthcare professional via manufacturer representative regarding a patient with an indication of spinal canal stenosis in need of spinal posterior fixation (lumbar) spinal therapy. It was reported that after performing olif at l4/5, position was changed to posterior position, and tlif was performed at l5/s. While psf was performed at l4/s, after placing the right rod, the left rod was inserted and fixed provisionally with set screws. The sound of tightening from the time of provisional fixing was strange, during the final tightening, the set screws idled, and could not be broken off. When the set screws were newly replaced and the angle of the screw heads were changed a little and it was tried to break off the screws again, the screws were broken off, so the procedure was completed. There was a delay of less than 60 mins in overall procedure time reported. There were no patient symptoms reported. There were no fragments in the patient reported. There were no further complications reported regarding the event.

 
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Brand NameCD HORIZON SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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 Key10533379
MDR Text Key206970045
Report Number1030489-2020-01277
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
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/15/2020
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 Number0673262W
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/26/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2018
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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