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U.S. Department of Health and Human Services

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

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 55750018570
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned device was not completed at the time of this report. A follow up report will be sent when analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with spinal therapy. It was reported that the driver broke during screw insertion. This was a revision surgery for l5/s radicular symptom. Screw was loosened and was removed. There was a delay of less than 60 min in overall procedure time. There was no fragment left in the patient. There were no symptoms reported. There were no further complications reported regarding the event.
 
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Brand NameCD HORIZON® SOLERA® VOYAGER¿ 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 Key12825967
MDR Text Key285471160
Report Number1030489-2021-01405
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00643169784017
UDI-Public00643169784017
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K170679
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,Followup
Report Date 03/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number55750018570
Device Catalogue Number55750018570
Device Lot NumberH5435405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2018
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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