MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 7X45MM S; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	186770445S
Medical Device Problem Codes	Compatibility Problem (2960); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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.H11 additional narrative: d2b.: additional pro-code: kwp, kwq.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.E3: reporter is a j&j sales representative.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
It was reported that this was a lumbar spine fusion (l5-s1) performed on an unknown date.It is unknown whether the jj products were used in the initial surgery or not.The second surgery was performed for extension fixation.The cause of the second surgery is unknown.In the surgery, the other company¿s cages were inserted at l3/4 and l4/5 via an anterior approach.After l5-s1 screws removal, extension fixation to l3-s1 was performed.After removal of a screw that had been inserted in the initial surgery, when the surgeon attempted to insert the screw in question, the screw behaved as if it was spinning.After checking the retightening of the instrument, which did not improve the situation, another product of the same size was used.The surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) viper prime cfxfn xtb 7x45mm s this is report 1 of 1 for complaint (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.Added: b5, b14 to capture dhr.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Device history review (dhr): a manufacturing record evaluation was performed for the finished device.Product code: 186770445s.Lot number: tbamiq.I was electronically reviewed and the following non-conformance has been observed: jbl-(b)(4) there is a burr on 1 of the 9 aql parts inspected.The nonconformance is unrelated to the reported complaint condition.The product was released on: 14-nov-2023.Manufacturing site:jabil le locle.Expiry date:30-sep-2028.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER PRIME CFXFN XTB 7X45MM S
• 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 ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19978162
• Report Number: 1526439-2024-02032
• Device Sequence Number: 19514297
• Product Code: NKB
• UDI-Device Identifier: 10705034530253
• UDI-Public: (01)10705034530253(17)380930(10)TBAMIQ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 186770445S
• Device Lot Number: TBAMIQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown