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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON SPINAL SYSTEM

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MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON SPINAL SYSTEM Back to Search Results
Model Number MSB_UNK_SCREW
Device Problem Migration (4003)
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 multiple displaced screws in the patient. The results also showed fractured screws bilaterally at the s1 vertebra. 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)
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis TN 85281
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis TN 85281
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key10014075
MDR Text Key189627796
Report Number1030489-2020-00486
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care 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 NumberMSB_UNK_SCREW
Device Catalogue NumberMSB_UNK_SCREW
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/04/2021
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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