MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL EXT TAB 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	179732640
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had a spine construct implanted (b)(6) 2023 from t10 to pelvis.The patient was implanted with 2 expedium rods, an unknown number viper and expedium screws, and two pelvic screws.Patient was experiencing pain and had a follow up (b)(6) 2023.During the follow up images identified 2 broken rods and an unknown number of migrated screws.The patient will be having a revision surgery on (b)(6) 2024.This report is for one (1) unk - mono/polyaxial screws: viper this is report 5 of 6 for complaint (b)(4).
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.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 - 510k: this report is for unk - mono/polyaxial screws: viper: rfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: part 179732640, lot 324983: the product was released on: october 15, 2021.Manufacturing site: jabil le locle.A manufacturing record evaluation was performed for the finished device and no nonconformances / manufacturing irregularities were identified during the manufacturing process.D9, h3, h6: a product investigation was completed: visual analysis of the returned sample revealed that there was no damage or defects with the device.The device has signs of implantation and explanation.The threads were found in good conditions.The migration/backout/pull-out/subsidence issues could be not confirmed since x-ray evidence was not provided.The current and manufactured to drawing was reviewed.The overall complaint was not confirmed as the device was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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: SI POLYAXL EXT TAB 6 X 40MM
• 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: 18703372
• Report Number: 1526439-2024-00894
• Device Sequence Number: 20637397
• Product Code: NKB
• UDI-Device Identifier: 10705034073866
• UDI-Public: 10705034073866
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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 Catalogue Number: 179732640
• Device Lot Number: 324983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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: UNK - RODS: EXPEDIUM; UNK - SCREWS: EXPEDIUM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female