MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 179702000

Device Problem Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

Additional procodes: kwp, kwq, mnh, mni, osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Date of concomitant therapy is (b)(6) 2022.Reporter is a synthes employee.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.(b)(4).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 Description

Device report from (b)(6) reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2022, due to a migrated rod.The surgeon plans to replace screw, rod, and setscrews.The setscrew on the l3 left had thoroughly come off.The setscrew on the l3 right was loose.The rods had come off the lesion.The screws on both sides (had been secured in the lesion.The setscrews, the rods, and the screws were replaced without issue.Patient originally underwent a primary plif procedure (l3/4) on (b)(6) 2022.Postoperative x-rays showed no issue.On (b)(6) 2022, patient was x-rayed again, and images confirmed that a rod had come off the lesion while setscrews had been tightened in place.This report is for a single-inner setscrew.This is report 2 of 4 for (b)(4).

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: d9 h3, h6: a manufacturing record evaluation was performed for the finished device product code: 179702000, lot number: 306735, it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 26/05/2021.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the single-inner setscrew exhibits marking consistent with the implantation and removal of the device.No defects or damage were identified.No x-rays to assess the looseness condition were provided.A dimensional inspection was unable to be performed due to device design.A functional test was not conducted since the mating device was not returned for examination as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the single-inner setscrew 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.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.D4: lot.

• Brand Name: SINGLE-INNER SETSCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 14696907
• MDR Text Key: 294036336
• Report Number: 1526439-2022-00850
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702000
• Device Catalogue Number: 179702000
• Device Lot Number: 306735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 7X50MM; MOSS MIAMI ROD 5.5X50MM TI; SINGLE-INNER SETSCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male