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

Model Number	188362031
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.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
It was reported that on (b)(6) 2020, during an unknown procedure upon attempting to contour the top tabs of the oc plate, the surgeons assistant severed the top tab completely off on three separate plates.All three plates appeared to break at the bend zone, two were removed from the field and sent to be cleaned, one remains in the patient under the surgeons clinical decision to use it.Fragments were generated and easily removed.Surgeon advised not to use the compromised plates, also reminded of the on label indications.The plate broke as it was being bent on the mayo stand and the fragment that broke off was removed.There was a surgical delay of unknown minutes.Patient status is unknown.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity unknown).This report is for one (1) mountaineer oct spinal system occipital plate 3.5 31mm.This is report 3 of 3 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 31MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11096683
• Report Number: 1526439-2020-02500
• Device Sequence Number: 16355397
• Product Code: MNI
• UDI-Device Identifier: 10705034158877
• UDI-Public: (01)10705034158877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MNTR OC PLATE SMALL; MNTR OC PLATE SMALL; MNTR OC PLATE SMALL; MNTR OC PLATE SMALL; MNTR OC PLATE SMALL; UNKNOWN SCREWDRIVERS; UNKNOWN SCREWDRIVERS