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: SPINEWAY SA TWIN PEAKS; HOLDER FOR LUMBAR CAGE
  • 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
 

SPINEWAY SA TWIN PEAKS; HOLDER FOR LUMBAR CAGE Back to Search Results
Model Number 026HLC1
Device Problem Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A new version of the cage holder 026hlc1 was released before the new versions the associated impactors 318hlp1 and 378hls1 were released.The designs of the new cage holder 026hlc1 is not compatible with the previous design of the impactors.If this instrument has reached the surgery room, it would have not been possible to implant the lumbar cage.In that case, an intervention would have been required to prevent permanent damage (absence of disc).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TWIN PEAKS
Type of Device
HOLDER FOR LUMBAR CAGE
Manufacturer (Section D)
SPINEWAY SA
7 allée du moulin berger
ecully, 69130
FR  69130
Manufacturer Contact
héloïse macaire
7 allée du moulin berger
ecully, 69130
FR   69130
MDR Report Key13576118
MDR Text Key288806698
Report Number3010758686-2022-00001
Device Sequence Number1
Product Code LXH
UDI-Device Identifier03663422600387
UDI-Public3663422600387
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K152355
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number026HLC1
Device Catalogue Number026HLC1
Device Lot Number4210074
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/29/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-