MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 LORDOTIC ROD-40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186788040S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Without a lot number, the device history records review could not be completed as no product was received.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for primary transforaminal interbody fusion l5/s1 surgery.During the surgery, when attempting to lock off set screws, the rod slipped out of the tulip and set screw was spinning in head of screw due to cross-threading.The surgery was completed with 25 minutes delay.There were no patient consequences are reported.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity unknown).This complaint involves three (3) devices.This report is for (1) viper2 lordotic rod-40mm.This report is 1 of 2 (b)(4).

Event Description

This report is 1 of 4 for (b)(4).

• Brand Name: VIPER2 LORDOTIC ROD-40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11865727
• MDR Text Key: 252904648
• Report Number: 1526439-2021-01029
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034238210
• UDI-Public: 10705034238210
• Combination Product (y/n): N
• PMA/PMN Number: K131802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186788040S
• Device Catalogue Number: 186788040S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MIS SINGLE INNER SETSCW; UNKNOWN SCREWDRIVERS; VIPER PRIME CFXFN XTB 7X40MM S