MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 STRAIGHT ROD-200MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186789200

Device Problem Break (1069)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: kwp;kwq;mnh;mni;osh.Complainant part is not expected to be returned for manufacturer review /investigation.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: a review of the receiving inspection (ri) for viper 2 straight rod was conducted identifying that lot number tburd was released in a single batch.Batch1: lot qty of (b)(4) units were released on 18 jun 2018 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.Device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 on (b)(6) 2021 the patient underwent for revision procedure (posterior lumbar spinal fusion between t10-l3) was performed for purulent spondylitis.The surgeon preoperatively presumed possible rod breakages.It was actually found that the rods on both sides had broken off.The patient outcome was unknown.On (b)(6) 2018 the primary percutaneous spinal fusion was performed.No further information is available.This complaint involves two (2) devices.This report is for (1) viper2 straight rod-200mm this report is 2 of 2 for (b)(4).

• Brand Name: VIPER2 STRAIGHT ROD-200MM
• 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
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12320156
• MDR Text Key: 266503314
• Report Number: 1526439-2021-01694
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034132969
• UDI-Public: 10705034132969
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111136
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186789200
• Device Catalogue Number: 186789200
• Device Lot Number: TBURD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VIPER2 STRAIGHT ROD-200MM
• Patient Outcome(s): Required Intervention