MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER 2 SYSTEM ROD, PRE-LORDOSED 75MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	186788075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported an unknown spine surgery occurred on (b)(6) 2018.Post operatively, the extended re-fusion surgery will be performed due to the adjacent intervertebral disorders.It is confirmed l4/5 achieved osteosynthesis.The plan is tlif for l2/3, and l5 might be removed depending on intraoperative decision.No further information is available.(b)(4).This report is for one viper 2 system rod, pre-lordosed 75mm for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: unknown event date e1: initial reporter is j&j company representative h3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A review of the receiving inspection (ri) for viper2 lordotic rod-75mm, was conducted identifying that lot number tbnan was released in two batches.Batch 1: lot qty of (b)(4) units were released on jul 21 2016 with no discrepancies.Batch 2: lot qty of (b)(4) units were released on jun 25 2016 with no discrepancies.Supplier: depuy: (b)(4).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.An analysis of the product could not be performed since a physical sample was not received for evaluation.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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.H4: device manufacture date corrected.

• Brand Name: VIPER 2 SYSTEM ROD, PRE-LORDOSED 75MM
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18475605
• Report Number: 1526439-2024-00494
• Device Sequence Number: 20563894
• Product Code: NKB
• UDI-Device Identifier: 10705034131801
• UDI-Public: (01)10705034131801
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 186788075
• Device Lot Number: TBNAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown