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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 54840016540
Device Problem Break (1069)
Patient Problem Spinal Column Injury (2081)
Event Date 11/01/2020
Event Type  malfunction  
Event Description
Information was received from a medtronic legal representative regarding a patient implanted with a screw in an unknown spinal therapy for an unknown spinal indication. It was reported that the patient sustained injuries from a broken screw in her back. There was no further information provided. No further complications were reported/ anticipated.
 
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.
 
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Brand NameCD HORIZON® SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key14268194
MDR Text Key290561701
Report Number1030489-2022-00427
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00613994592385
UDI-Public00613994592385
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number54840016540
Device Catalogue Number54840016540
Device Lot NumberH11F3224
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/26/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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