MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR OC PLATE SMALL; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 188362031

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is (b)(6).The investigation could not be completed, no product was received; 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 (b)(6) reports an event as follows: it was reported that on an unknown date, during an unknown procedure the surgeon could not finally tighten the lateral mass screw using the x15 torque driver.Upon opening a second backup set that had another x15 torque driver, the screw was able to achieve final tightening and torqued out.The two mountaineer oc plates broke in the case as well as the final tightener.It is unknown if fragments were generated and removed.Procedure was completed without surgical delay.Patient outcome was unknown.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This complaint involves three (3) device.This report is for (1) mntr oc plate small.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).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: d4: udi.D11: concomitant product added to complaint.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.11.Corrected data g1.

• Brand Name: MNTR OC PLATE SMALL
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11097358
• MDR Text Key: 250520837
• Report Number: 1526439-2020-02515
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034158877
• UDI-Public: 10705034158877
• Combination Product (y/n): N
• PMA/PMN Number: K151885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 188362031
• Device Catalogue Number: 188362031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Patient Sequence Number: 1
• Treatment: MNTR OC PLATE SMALL; MNTR OC PLATE SMALL; UNKNOWN SCREWS; UNKNOWN SCREWS; X15 TORQUE DRIVER; X15 TORQUE DRIVER