• 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 ELEVATE¿ SPINAL SYSTEM 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
 

MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE¿ SPINAL SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number NAV2132
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
Event Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having mis l4-s1 fusion due to unknown indication. It was reported that inserter broke near the handle as we were impacting the cage into place. Nobody was harmed during the incident and the inserter did not actually fall apart until after the case. Cages were implanted successfully and no complications were caused. There was no patient symptom reported. There were no further complications reported regarding the event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameELEVATE¿ SPINAL SYSTEM
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key14218474
MDR Text Key290152220
Report Number1030489-2022-00408
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163581
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNAV2132
Device Catalogue NumberNAV2132
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-