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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. LUMBAR SPINE SCREWS SOLERA; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDTRONIC SOFAMOR DANEK USA, INC. LUMBAR SPINE SCREWS SOLERA; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 55740106550
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  Injury  
Event Description
Broken s1 screw."xxx555; xxx545".
 
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Brand Name
LUMBAR SPINE SCREWS SOLERA
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC.
MDR Report Key17004791
MDR Text Key316054759
Report NumberMW5117865
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number55740106550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/24/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Hospitalization;
Patient Age72 YR
Patient SexMale
Patient Weight97 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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