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

Model Number	186789200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional 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 tbtwd was released in a single batch.Batch1: lot qty of (b)(4) units were released on 05 apr 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 or Problem 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 1 of 2 for (b)(4).

• Brand Name: VIPER2 STRAIGHT ROD-200MM
• Common Device Name: 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: 12320136
• Report Number: 1526439-2021-01693
• Device Sequence Number: 11805517
• Product Code: NKB
• UDI-Device Identifier: 10705034132969
• UDI-Public: 10705034132969
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186789200
• Device Catalogue Number: 186789200
• Device Lot Number: TBTWD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIPER2 STRAIGHT ROD-200MM
• Outcome Attributed to Adverse Event: Required Intervention