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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES SPINE / MEDOS INTERNATIONAL SARL DEPUY SYNTHES THORACIC STRAIGHT PROBE PEDICLE FINDER ORTHOPEDIC STEREOTAXIC INSTRUMENT

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DEPUY SYNTHES SPINE / MEDOS INTERNATIONAL SARL DEPUY SYNTHES THORACIC STRAIGHT PROBE PEDICLE FINDER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 279702030N
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 10/06/2021
Event Type  Injury  
Event Description
Thoracic straight probe broke while in use. Both pieces retrieved. Used a broken screw removal set to remove the working end from the patient's bone. Surgery proceeded as planned. Fda safety report id# (b)(4).
 
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Brand NameDEPUY SYNTHES THORACIC STRAIGHT PROBE PEDICLE FINDER
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY SYNTHES SPINE / MEDOS INTERNATIONAL SARL
raynham MA
MDR Report Key12665029
MDR Text Key277878937
Report NumberMW5104767
Device Sequence Number1
Product Code OLO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number279702030N
Device Catalogue Number279702030N
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

Patient Treatment Data
Date Received: 10/19/2021 Patient Sequence Number: 1
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