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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCREW; SCREW, FIXATION, BONE

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SCREW; SCREW, FIXATION, BONE Back to Search Results
Device Problem Failure to Align (2522)
Patient Problems Failure of Implant (1924); Nerve Damage (1979)
Event Date 07/25/2022
Event Type  Injury  
Event Description
On (b)(6) 2022 the patient had a mazor robot assisted spine surgery.The patient experienced lower extremity radiculopathy and a ct if the spine was performed on (b)(6) 2022.The patient was readmitted on (b)(6) 2022 for a revision related to suspected misaligned screws.Fda safety report id # (b)(4).
 
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Brand Name
SCREW
Type of Device
SCREW, FIXATION, BONE
MDR Report Key15401708
MDR Text Key299768464
Report NumberMW5111961
Device Sequence Number2
Product Code OLO
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 09/07/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient SexFemale
Patient Weight66 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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