MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 9X80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	179704980
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an interbody fusion (t7-s2) for asd (adjacent segment disease) was performed on (b)(6) 2024.The surgery was completed successfully with no surgical delay.After the surgery, the screw inserted into s2 was found to be out of place.There were no symptoms caused by the event and there are no plans to reinsert the screw.The patient outcome was reported to be stable.No further information is available.
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.H11 additional narrative: d4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.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.H11 additional narrative: added: b14 (to capture dhr), b5 h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary 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 review (dhr): a review of the receiving inspection (ri) for viper ti sai poly 9x80mm, was conducted identifying that lot number tbakce was released in one batch.Batch1: lot qty of (b)(4) units are released on aug 05, 2022 with no discrepancies a review of the receiving inspection (ri) for viper ti sai poly 9x80mm, was conducted identifying that lot number tbaktk was released in one batch.Batch1: lot qty of (b)(4) units are released on jan 20, 2023 with no discrepancies supplier: (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.Device history review (dhr): the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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
Additional information was received and stated that the patient was in stable condition.

• Brand Name: VIPER TI SAI POLY 9X80MM
• 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 Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 20223275
• Report Number: 1526439-2024-02431
• Device Sequence Number: 20797829
• Product Code: NKB
• UDI-Device Identifier: 10705034265841
• UDI-Public: (01)10705034265841
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: 179704980
• Device Lot Number: TBAKTK/TBAKCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown