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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 1556300500
Device Problems Migration (4003); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2020
Event Type  malfunction  
Manufacturer Narrative
510(k) for similar product marketed in us with catalogue # 1476200500 is k132111. Evaluation of the returned device was not completed at the time of this report. A follow up report will be sent when analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of traumatic vertebral fracture (3 vertebral bodies of l1. L2. L5). It was reported that after the procedure the set screws on both sides of the fixed lower level(s2)had loosened, according to the image, the rod had moved. Product remains implanted in patient. The loosening was suspected and confirmed on july 27. It was very probably that it occurred immediately after walking and sitting on the bed were allowed at about 2 weeks after operation. There were no patient symptoms or complications as a result of this event. Bone graft had not been performed because it was a trauma, and ps was not inserted in s1, and ballast had been inserted in s2ai. Ins trumentations were th10,11,12,l1,2,3,4 and 5, anchor had been inserted in s2ai, and bone graft had only been performed at l1,2,3. An additional operation was performed on august 5. The backing out and loose of the set screw occurred, but it was unknown whether the event was caused by screw or set screw.
 
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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 Key10500866
MDR Text Key222287592
Report Number1030489-2020-01221
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1556300500
Device Catalogue Number1556300500
Device Lot Number0718992W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/08/2020 Patient Sequence Number: 1
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