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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC SCREW EXTENDER PEDICLE SCREW SPINAL SYSTEM ADOLESCENT IDIOPATHIC SCOLIOSIS

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MEDTRONIC, INC. MEDTRONIC SCREW EXTENDER PEDICLE SCREW SPINAL SYSTEM ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Model Number 7578302
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2019
Event Type  Malfunction  
Event Description

Pt went posterior thoracic decompression, t 8-10 instrumentation, fusion, during the surgery while using the medtronic screw extender, 2 pieces broke off the main body and were immediately recovered. Fda safety report id# (b)(4).

 
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Brand NameMEDTRONIC SCREW EXTENDER
Type of DevicePEDICLE SCREW SPINAL SYSTEM ADOLESCENT IDIOPATHIC SCOLIOSIS
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key9552546
MDR Text Key173950054
Report NumberMW5092025
Device Sequence Number1
Product Code OSH
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 01/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7578302
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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