MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188362031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: kwp and nkg.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during and unknown procedure that the plate broke prematurely during breaking.There were no fragments generated.There was no surgical.There was no consequence to the patient.This report involves one (1) mountaineer oct spinal system occipital plate 3.5 31mm.This is report 1 of 1 for (b)(4).

• Brand Name: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM
• Common Device Name: 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: 11030699
• Report Number: 1526439-2020-02432
• Device Sequence Number: 13620256
• Product Code: MNI
• UDI-Device Identifier: 10705034158877
• UDI-Public: (01)10705034158877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 188362031
• Device Catalogue Number: 188362031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1