• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFN XTB 6X40MM S THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

  • 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
 

MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFN XTB 6X40MM S THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 186760440S
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  malfunction  
Manufacturer Narrative
Additional procodes: kwp, kwq. A review of the receiving inspection (ri) for viper prime cfxfen xtab 6x40mm-sterile was conducted identifying that lot number tbzzy was released in a single batch. Batch1: manufactured on october 07, 2019 and released on october 24, 2019 with no discrepancies. As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer. The device history record (dhr) of product code 186750440s, lot tbaabn, was reviewed and no non-conformances were observed during the manufacturing process. The product was manufactured on september 06, 2019 and released on october 09, 2019. The dhr was electronically reviewed. Visual inspection: the viper prime cfxfn xtb 6x40mm s (p/n: 186760440s, lot number: tbzzy) was received at us customer quality (cq). Visual inspection of the complaint device showed the received device was actually 186750440 lot number tbaabn. Packaging stickers were included as well displaying 186750440, tbaabn on them. Dimensional inspection: a dimensional inspection was performed to ensure the device etch was correct and not misprinted. Measured dimensions: screw major diameter
=
conforming. Document/specification review: current) and manufactured revisions were reviewed. No design issues or discrepancies were identified. Investigation conclusion: this complaint is confirmed as the wrong label was used for the device and packaging. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that during surgery of lumbar disc nucleus pulposus resection with conical laminectomy, the sterile packing was opened, but the product was not the one expected. Another device was used to complete the surgery. There were no adverse consequences to the patient. Upon manufacturer investigation, it was determined that a labelling issue had occurred. This report is for a viper prime cfxfn xtb 6x40mm s. This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVIPER PRIME CFXFN XTB 6X40MM S
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 
SZ  
6103142063
MDR Report Key11359440
MDR Text Key234322324
Report Number1526439-2021-00336
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034530086
UDI-Public(01)10705034530086
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K173095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186760440S
Device Catalogue Number186760440S
Device Lot NumberTBAABN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-