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 Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a spinal fusion procedure treating rheumatism was performed.In order to shape the plate to the contour of the occipital bone, the surgeon bent the plate gradually.Then its distal side broke.The procedure was completed with a replacement.No further information is available.This report is for one (1) mountaineer oct spinal system occipital plate 3.5 31mm.This is report 1 of 1 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.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.
Additional Manufacturer Narrative
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.The mntr oc plate small (p/n: 188362031, lot #: wa23284) was returned and received at us cq.Upon visual inspection, it was observed to be broken.No more issues were identified with the returned device.The complaint condition was confirmed for the mntr oc plate small (p/n: 188362031, lot #: wa23284).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 history lot a review of the receiving inspection (ri) for mntr oc plate small was conducted identifying that lot number wa23284 was released in a single batch.Batch1: lot qty were released on 27 jul 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9903924
• Report Number: 1526439-2020-00805
• Device Sequence Number: 10951160
• Product Code: NKG
• UDI-Device Identifier: 10705034158877
• UDI-Public: (01)10705034158877
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

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
• Device Lot Number: WA23284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/02/2020; 04/24/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/23/2020; 05/07/2020
• Patient Sequence Number: 1