• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEPUY SYNTHES THORACIC STRAIGHT PROBE PEDICLE FINDER
Type of Device
ORTHOPEDIC 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 Nurse
Type of Report Initial
Report Date 10/15/2021
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 Model Number279702030N
Device Catalogue Number279702030N
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/19/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight119
-
-