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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SOLERA VOYAGER 5.5 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG SOLERA VOYAGER 5.5 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 6534530
Device Problem Mechanics Altered (2984)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/22/2020
Event Type  Injury  
Manufacturer Narrative

Product was returned and analysis is yet to begin. A follow-up report will be sent once analysis is completed. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with screws using a driver for a l3/5 olif and posterior spinal fixation. It was reported that the tip of the driver that was broken at this time got stuck in the screw shaft, and because the tip was difficult to be removed during operation, screw was removed. During posterior spinal fixation, after screw was inserted, when an attempt was made to perform additional insertion of screw for adjusting the position by the reported driver, the tip of the driver broke and got stuck in the bone screw. Therefore, a short rod was placed and the screw was removed. The screw broke and there was no fragment of the screw remaining in the patient's body. The screw was never implanted (screw #1). When the set screw was pushed down in a state of short tab, the tab widened even though it was not cross-threaded, so the set screw became difficult to be pushed down. The size of tap was reduced by one size. In addition, since set screw idled when it was inserted, the set screw was removed and replaced with another screw. When checking the screw that was removed, it was found the tab was deformed. The set screw was discarded. The screw broke and there was no fragment of the screw remaining in the patient's body. The screw was never implanted (screw #2). During inserting screw additionally by the reported driver, the tip of the driver broke. The driver broke and there was no fragment of the driver remaining in the patient's body. The reason of the event is thought that since the driver was used for a patient with hard bones, the hardness of the tip is less than bone, so the tip broke. Screw #4 idled and the thread screw #5 was damaged. There were no patient symptoms or complications as a result of the event. The pre- op diagnosis was progress of degeneration, bladder disturbance, and radicular symptom at both sides of l5. The patient had severe bone sclerosis. The levels implanted were l3- l5. The reason for revision surgery was that fixation was performed at thoracic previously and this time, the operation was performed because symptom appeared at the lumbar level. The product was used without an extender because it was necessary to perform decompression and the procedure was changed to open. The hcp said that no method could be done due to the bone sclerosis. The date of initial surgery was (b)(6) 2020. The initial surgery was a thoracic decompression and posterior spinal fixation (th10/11). The initial surgery was performed using solera 4. 75 spinal system. No health damage in the patient was reported. The screw #1 and driver were replaced by medtronic products. No further complications were reported/ anticipated.

 
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Brand NameSOLERA VOYAGER 5.5
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao,pr TN 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao,pr TN 00792
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10571802
MDR Text Key210589875
Report Number1030489-2020-01330
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK170679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6534530
Device Catalogue Number6534530
Device LOT NumberH5618055
Was Device Available For Evaluation? No
Date Returned to Manufacturer09/07/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/23/2020
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: 09/23/2020 Patient Sequence Number: 1
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