MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DI POLY SCREW 10X55MM TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 179722155

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2023

Event Type  malfunction  

Event Description

Device report from japan reports an event as follows: it was reported that patient underwent surgery on (b)(6) 2018.In the surgery, l4 to s were fixed with matrix implants.Postoperatively, adjacent segment disease (asd) occurred, and a revision surgery was performed on (b)(6) 2023.During the revision surgery, the matrix screw at left-side s was found to be loose, and was to be replaced with an expedium screw di10.0×55.During insertion of the expedium screw, the tip of the screwdriver was damaged and caught inside the core, making it impossible to proceed with screw insertion.The screw was extracted and another expedium screw (di10.0×45) was inserted.The revision surgery was completed successfully within thirty minutes delay.Patient was stable.This report is for an exp di poly screw 10x55mm ti.This is report 1 of 1 and captures the intraoperative incident.The cause of the revision surgery is captured under (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.H10 additional narrative: 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.

• Brand Name: EXP DI POLY SCREW 10X55MM TI
• 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: 17503483
• MDR Text Key: 321372013
• Report Number: 1526439-2023-01462
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034070179
• UDI-Public: (01)10705034070179
• 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,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: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 179722155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• 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
• Treatment: XPDM QUICK-CON DI POLY SCWDRVR