MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH DUAL DIAMETER ROD 3.5X5.5, 600; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number 188311012

Device Problem Break (1069)

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

Event Date 02/24/2024

Event Type  malfunction  

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.H10 additional narrative: d2b: additional product code: kwp, mni d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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 Description

It was reported that spinal rod broke four years post-op, patient has manual labor job (construction) and heard loud pop when picking up tool bag, no immediate pain but followed up with clinician and it was found that rod had broken.Patient is fully healed, no pain or discomfort in the area, no fragment generation, all other implants (pedicle screws) appear to be in tact.There was posterior cervicothoracic fusion, c6 to t10.Initial implantation occurred in 2020.Patient had a ct scan last week to confirm no additional hardware breakage, which was confirmed.Only the single rod failed.Patient has no pain or indications for removal, therefore the implants remain in the patient with no anticipation of removal.There was no patient outcome.This report is for one (1) dual diameter rod 3.5x5.5, 600 this is report 1 of 1 for complaint (b)(4).

• Brand Name: DUAL DIAMETER ROD 3.5X5.5, 600
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• 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 ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 18928659
• MDR Text Key: 337965549
• Report Number: 1526439-2024-01076
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034156606
• UDI-Public: (01)10705034156606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 188311012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male