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

Catalog Number	188362031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mntr oc plate small broke during the surgery on (b)(6) 2024.Another device was used to complete the surgery.There were no adverse consequences to the patient.There was no surgical delay.This report is for one (1) mntr oc plate small this is report 1 of 1 for complaint (b)(4).
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.Udi: the expiration date is not available.Therefore, the full udi is currently not available.A photo investigation was conducted.The photo investigation revealed the implant was broken from the distal hole.Broken fragment was not observed on image provided.A complete potential cause cannot be established with available information.A product investigation was conducted.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the distal hole was broken off from the bent zone.Broken fragment was not returned for evaluation.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces while usage.Surgical technique mountaineer oct spinal system was reviewed and the following relevant statements were found at page 17: to contour the oc plate, place it securely in the bender and gently bend to desired radius.The contouring should be performed only in the bend zones to avoid damage to the sliding connectors.The oc plate can be bent to a maximum of 15° in either direction.Note: to maintain the integrity of the occipital, the oc plate must be bent in one direction only.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the mntr oc plate small would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A review of the receiving inspection (ri) for mntr oc plate small, was conducted identifying that lot number wa33575 as released in one batch.Batch1: lot qty of (b)(4) units are released on oct 05, 2022 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.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: MNTR OC PLATE SMALL
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 19832447
• Report Number: 1526439-2024-01927
• Device Sequence Number: 8150255
• Product Code: NKG
• UDI-Device Identifier: 10705034158877
• UDI-Public: (01)10705034158877
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 188362031
• Device Lot Number: WA33575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male