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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM

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WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM Back to Search Results
Model Number X06123255
Device Problem Fracture (1260)
Patient Problems Pain (1994); Tingling (2171); Stenosis (2263); Injury (2348); Numbness (2415)
Event Type  Injury  
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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported as per a litigation complaint that the patient underwent a surgery. On an unknown date, post-op, due to increasing pain at the implanted site, the patient underwent an mri on (b)(6) 2019. The results showed fractured screws bilaterally at the s1 vertebra. Additionally, multiple displaced screws in the patient was also reported. On (b)(6) 2019, the surgeon performed a revision surgery. The patient's post-operative diagnosis was a failure of arthrodesis of lumbar instrumentation. Reportedly, the patient also suffered from unspecified injuries.
 
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Brand NameCD HORIZON SPINAL SYSTEM
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw,in TN 46582
Manufacturer (Section G)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw,in TN 46582
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key10014043
MDR Text Key189627164
Report Number1030489-2020-00485
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113174
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberX06123255
Device Catalogue NumberX06123255
Was Device Available for Evaluation? No
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? No
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: 04/30/2020 Patient Sequence Number: 1
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