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

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).

• Brand Name: VIPER PRIME CFXFN XTB 6X40MM S
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 11359440
• MDR Text Key: 234322324
• Report Number: 1526439-2021-00336
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034530086
• UDI-Public: (01)10705034530086
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186760440S
• Device Catalogue Number: 186760440S
• Device Lot Number: TBAABN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1