MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER 2 SYSTEM ROD, PRE-LORDOSED 85MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	186788085
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 that this was an original unknown surgery occurred on (b)(6) 2020.Post-operatively on an unknown date, adjacent segment disease (asd) occurred.A revision surgery occurred to extend fixation and remove hardware on (b)(6) 2023.The sfx cross-link was removed.Set screw and rod were removed.Of the screws in l3-5, only l3 and l4 screws were removed.(bone fusion was completed) l5 screw were preserved.Additional screw of 7.0-45mm diameter was inserted.L5-s tlif was performed.(cage was other company¿s product.) sfx cross-link was placed, and the final tightening was done.This report is for one viper 2 system rod, pre-lordosed 85mm for (b)(4).(b)(4) are linked.Additional impacted products are captured for the event.
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.B3: unknown when asd occurred.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10 concomitant therapy date (b)(6) 2020.E1: initial reporter is j&j company representative h4: device history a review of the receiving inspection (ri) for viper2 lordotic rod-85mm was conducted identifying that lot number was released in one batch.¿ batch1: lot qty of 351 units were released on 18 apr 2018 with no discrepancies.Supplier : depuy : (b)(6) 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.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.

• Brand Name: VIPER 2 SYSTEM ROD, PRE-LORDOSED 85MM
• 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: 18597335
• Report Number: 1526439-2024-00730
• Device Sequence Number: 18172005
• Product Code: NKB
• UDI-Device Identifier: 10705034131825
• UDI-Public: (01)10705034131825
• 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: 2020
• Device Explanted Year: 2023
• 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

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: 186788085
• Device Lot Number: TBUPY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X50MM; 5.5 TI CORT FIX 7X50MM; CONCORDE PROTI, 5DG,9X10X27 MM; SFX,5.5,TI, MED, SIZE A6; VIPER2 LORDOTIC ROD-85MM; VIPER2 LORDOTIC ROD-85MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown