MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCR 5.0X35; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 199721535S

Device Problem Material Integrity Problem (2978)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a synthes employee.The device history record (dhr) of product code: 199721535s lot: 300458 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: february 12, 2021.Photo investigation: the device was not returned.A photo-investigation was performed on the received images.The pictures were the explanted devices which appeared not cleaned yet.The picture revealed an expedium verse screw head which appeared to have torn threads; hence the complaint is confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition is confirmed during photo investigation, as the thread of the screw head was observed to have damage thread; however it is not confirm whether the damage occurred during or before explantation of the device.No new, unique, or different patient harms were identified as a result of this evaluation.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 preventive 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.

Event Description

Device report from the (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, 2 expedium verse screws were damaged.Replacement correction keys were used instead.Procedure was completed successfully with an unknown delay.Patient status is unknown.Upon manufacturer receipt and investigation, it was determined that the device had peeling threads.This report is for a 5.5 expedium verse screw 5.0x35.This is report 1 of 2 for (b)(4).

• Brand Name: 5.5 EXP VERSE SCR 5.0X35
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 12294823
• MDR Text Key: 265615230
• Report Number: 1526439-2021-01640
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034443584
• UDI-Public: (01)10705034443584
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721535S
• Device Lot Number: 300458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• 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: 5.5 EXP VERSE DI SET SCR