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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 Crack (1135)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/11/2022
Event Type  malfunction  
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient having preoperative diagnosis for reinforcement surgery due to bilateral rod breakage. Initial surgery or the procedure taken was t9/s2 fixation with the degenerative kyphoscoliosis it was reported that due to broken rods on both sides, reinforcement was performed using a connector from another company. Although it is not a broken piece, the broken rods on both sides are left as is and reinforcement is performed with connectors. Initial surgery was performed on (b)(6) 2020. There were no symptoms reported. There were no further complications reported regarding the event. The broken rods are still in use as they are. They were broken but were not separated into plural pieces/fragments. So, no fragments are remaining inside the patient body. The report indicates 'broken' but the actual condition of the rods seems to be closer to 'having cracks'. There is no plan to remove them.
 
Manufacturer Narrative
510k number : the device p/n 1556300500 is similar to the device manufactured in us p/n 1556000500. Hence, mentioned 510k license number k111942 is of p/n 1556000500. 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.
 
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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
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key14299361
MDR Text Key291476665
Report Number1030489-2022-00436
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 Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1556300500
Device Catalogue Number1556300500
Device Lot Number0691218W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/20/2018
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: 05/06/2022 Patient Sequence Number: 1
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