MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199721000

Device Problems Break (1069); Crack (1135)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Additional procodes: kwp, kwq, mnh, mni, osh.Reporter is a synthes employee.The device history record (dhr) of product code: 199721000, lot: 290277 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: october 13, 2020.Visual inspection: the verse correction key was returned and received at us customer quality (cq).Upon visual inspection, the distal threads of the poly lock (p/n: p/n: 887010007) were observed to be peeled and broken and the broken threads were not returned.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: functional test cannot be performed as the device was returned by itself.However, the broken threads would have contributed to the complaint condition.Dimensional inspection: a dimensional inspection was not performed due to post manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Expedium verse - dual lock assembly investigation conclusion the complaint condition is confirmed for the verse correction key.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.

Event Description

Device report from austria reports an event as follows: it was reported that during a scoliosis procedure on (b)(6) 2021, when inserting the correction key, (2) of them tilted.(1) screw was fixed with the unitized set screw and the other screw was not fixed at all.There was a (15) minutes surgical delay due to the reported event.The procedure was successfully completed.No patient consequences reported.This report is for a verse correction key.This is report 2 of 3 for (b)(4).

• Brand Name: VERSE CORRECTION KEY
• 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: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 11938560
• MDR Text Key: 258294117
• Report Number: 1526439-2021-01098
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: (01)10705034466132
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 290277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1