MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186715000

Device Problem Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional procode: kwp; kwq; mnh; mni; osh.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 synthes reports an event in (b)(6) as follows: on (b)(6) 2021 it was reported that the patient underwent a spinal fusion at l3 left treating interbody fracture.On (b)(6) the patient was x-rayed in the medical follow-up.It was found that the setscrew at l3 had come off.On mar.17 the patient underwent a revision procedure.They also found that the inside of the monoaxial screw had been damaged.No fragment was left in the patient¿s body.The surgeon commented that the patient had a large physique which might have put stress to the devices.No further information is available.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).This report is for one (1) mis single inner setscw.This is report 2 of 2 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.The dhr of product code: 186715000 lot : 275811 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 06.03.2020 qty:(b)(4) the product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the external threads were deformed in the mis single inner setscw implant.The dimensional inspection was not performed due to the post-manufacturing damage.The functional test cannot be performed due to the device's external thread feature damage.The deformed condition of the screw external threads was consistent with a random component failure that may have been caused by exposure to unintended/overt forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as visual inspection of the received device identified deformation of the external threads.While no definitive root cause could be determined, it is probable that the observed deformation caused the alleged functional issue.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.Drawing/specifications reviewed?: the following drawing reflecting the current and manufacture revision was reviewed.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: MIS SINGLE INNER SETSCW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11666422
• MDR Text Key: 245495099
• Report Number: 1526439-2021-00721
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034121192
• UDI-Public: 10705034121192
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186715000
• Device Catalogue Number: 186715000
• Device Lot Number: 275811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 05/13/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS; VIPER MONO SCREW 7X45MM TI
• Patient Outcome(s): Required Intervention