MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP5.5 320MM CONTOUR COCR ROD; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	196791320
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
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.Additional product codes: kwp, kwq, mnh and nkb.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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
Device report from synthes reports an event in australia as follows: the dr.Operated on patient on (b)(6) 2022.When revising this construct it was noted that the left lumbar rod had broken.Rod was removed and replaced with a cocr rod and new set screw used to lock down this construct.This revision was a revision of a 2019 and 2017 construct.I have included the rod from the 2017 case but this case was revisited in 2019 and i was not made aware of this.Patient status/ outcome/consequences: there was a clinical outcome experienced by the patient; a broken rod.This report is for one (1) exp5.5 320mm contour cocr rod.This is report 1 of 1 for complaint (b)(4).

• Brand Name: EXP5.5 320MM CONTOUR COCR ROD
• Common Device Name: ORTHOSIS, SPINAL PEDICLE 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 ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 16194348
• Report Number: 1526439-2023-00079
• Device Sequence Number: 14904729
• Product Code: MNI
• UDI-Device Identifier: 10705034295299
• UDI-Public: (01)10705034295299
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082942
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 196791320
• Device Catalogue Number: 196791320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male