Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ORTHOPEDIC MANUAL SURGICAL 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
 

MEDTRONIC SOFAMOR DANEK USA, INC ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 7480113
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/17/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient underwent thoraco lumbar arthrodesis.Intra-op, key of the driver broke.No patient complications were reported.No fragments of the product remained inside the product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key8762219
Report Number1030489-2019-00701
Device Sequence Number14027562
Product Code LXH
UDI-Device Identifier00721902861468
UDI-Public00721902861468
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/04/2019
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
Operator of Device Health Professional
Device Catalogue Number7480113
Device Lot NumberPR17D001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/04/2019
Initial Report FDA Received Date07/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-