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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 1556300500
Device Problem Use of Device Problem (1670)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 09/03/2021
Event Type  malfunction  
Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. This device is not approved for sale in us but a similar device with catalog # 1556200500, 510k# k131321 and udi (b)(4) is approved for sale in us. This event is serious injury reportable. Since the device is not marketed in the us, the device is reported as a malfunction for a similar device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare provider (hcp) via the manufacturer representative regarding an event which occurred post an initial t9/s2 psf l2/3 plif l4 pso procedures in a patient diagnosed with lumbar kyphosis. It was reported that the products explanted due to postoperative transverse process fracture. The hooks on both sides used for the t9 transverse process were removed. There was no malfunction with the hooks themselves. The cranial rods were too long and could almost be touched through the skin, so the rods were cut. There are no reports of defects or adverse events for the rod. Doctor cut 50 cm rods and use them, so there is no problem with the size of the rod as a product. It seems to be a problem when installing. The doctor intentionally cut a rod that was too long during the reoperation. No other patient injury / complication was reported.
 
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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
david gustafson
1800 pyramid place
memphis, TN 38132
7635149628
MDR Report Key12511253
MDR Text Key272657274
Report Number1030489-2021-01190
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 Other Health Care Professional
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1556300500
Device Catalogue Number1556300500
Device Lot Number0801118W
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 Received09/03/2021
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

Patient Treatment Data
Date Received: 09/22/2021 Patient Sequence Number: 1
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