MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 186715000

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/31/2022

Event Type  Injury  

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.Additional product codes: mnh, kwq, osh, mni and nkb.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6) hospital, organization for promotion of regional medical function isoji 1-7-1, minato-ku, osaka city, japan, osaka 552-0003, japan 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.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 japan as follows: it was reported that this was a percutaneous posterior spinal fusion for stenosis on (b)(6) 2022.The set screw in question was idled when the torque was applied and tightened.The cross-thread was confirmed.The operation was completed with a new replacement.Then, the tab of the screw was broken irregularly at the 0.5 to 1 mm part of the connecting part when the tab was cut as per surgical technique.The remain of the tab has left in the screw head.The surgeon determined that there was no harm on the patient and removal was impossible.The surgery was completed successfully without any surgical delay.Patient status: stable.No further information is available.This report is for one (1) mis single inner setscw this is report 1 of 3 for complaint (b)(4).

• Brand Name: MIS SINGLE INNER SETSCW
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15458849
• MDR Text Key: 300297825
• Report Number: 1526439-2022-01647
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10705034121192
• UDI-Public: (01)10705034121192
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention