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: LINVATEC CORP. C-WIRE WIRE FXTN 0.062X51IN #316; PIN, FIXATION, SMOOTH
  • 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
 

LINVATEC CORP. C-WIRE WIRE FXTN 0.062X51IN #316; PIN, FIXATION, SMOOTH Back to Search Results
Model Number 00505004900
Patient Problems Failure of Implant (1924); Paraplegia (2448)
Event Date 01/12/2022
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2022, during an anterior cervical discectomy and fusion acdf c4/5 possible removal of the existing zimmer cervical plate due to adjacent level disease, it was previously implanted at cr-7, the surgeon was using acis set to implant an acis pro ti cervical graft.The surgeon either has to use zero p at c4/5 or remove the plate to use acis and skyline.He ended up removing the plate and used acis and a skyline single-level plate.He inserted the implant and upon removal of the inserter realized it was too far.The patient partially lost motors from the chest down.(no equipment broke or malfunctioned).A variety of instruments were used to remove the spacer which he was able to do.A new graft was placed, the plate was removed but not replaced and implanted with screws.Once the case was completed neuro monitoring showed that one side of her body was getting some motor response while the other side was not.There was a surgical delay when the graft had to be removed.The patient was taken to the icu and had not progressed very well.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref reports: mw5120547, mw5120548, mw5120549, mw5120550, mw5120551 and mw5120553.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
C-WIRE WIRE FXTN 0.062X51IN #316
Type of Device
PIN, FIXATION, SMOOTH
Manufacturer (Section D)
LINVATEC CORP.
MDR Report Key17458506
MDR Text Key320563624
Report NumberMW5120552
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 08/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number00505004900
Device Lot Number488949
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/03/2023
Patient Sequence Number1
Treatment
LIFENET - GRFT BONE SUB SM 1ML FRMBL LATXFREE VIVIGEN BL (LEFT FOOT), PRODUCT# BL-1600-001, LOT# 21130578044; LIFENET - GRFT BONE SUB SM 1ML FRMBL LATXFREE VIVIGEN BL (RIGHT FOOT), PRODUCT# BL-1600-001, LOT# 21130578044; MEDTRONIC SPINAL & BIOLOGICS-ROD SPNL 40 DIA3.5 LATXFREE INFINITY OCT, PRODUCT# 3603740, LOT # UNK; MEDTRONIC SPINAL & BIOLOGICS-SCR SPNL 10 DIA3.5 LATXFREE INFINITY OCT, PRODUCT# G3603510, LOT# UNK. ; MEDTRONIC SPINAL & BIOLOGICS-SCR SPNL 12 DIA3.5 LATXFREE INFINITY OCT, PRODUCT# 3603512, LOT # UNK; MEDTRONIC SPINALGRAFT-SYR DBM GEL 5CC FLWBL GRAFTON, PRODUCT# T44145, LOT # A49974078
-
-