MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 480 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	179762480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that this was an asd for lumbar kyphosis on an unknown date.The patient had not been to the outpatient clinic for about the last three years.On an unknown date, the patient came to the outpatient clinic due to pain, and the surgeon confirmed the rod breakage.The revision surgery was performed on (b)(6) 2023 due to the rod breakage.The event date is unknown.In the revision surgery, s1 and s2 set screws were removed.Sfx between l5 to s1 were removed.The rods on both side between l5 to s1 to s2 were removed.Sfx between l3 to l4 were removed.Four of top notch uc were placed between l3 to l4 and l4 to l5 on both side.The transverse rod connector 40mm were cut and installed on s2 sai screw on both sides.S1 expedium screw with lateral connectors 20 mm were placed on both sides.Two of rod120mm were placed on inside the pedicle screw.The final fastening was performed.The surgeon confirmed the pseudarthrosis between l5-s1.He believes that the pseudoarticulation is the cause of the breakage of the rods in question.The rod breakage occurred bilaterally between l5 and s1.They were broken on both sides directly below l5 screw and directly above sfx installed between l5 and s1.There are no pieces in the patient.The surgeon confirmed by x-ray.No further information is available.This report is for one (1) rod, 480 mm.This is report 1 of 2 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.H10 additional narrative: d2b: additional product code: osh,mnh,kwp,mni and kwq.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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
The patient outcome was reported to be stable.

• Brand Name: ROD, 480 MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 18394874
• Report Number: 1526439-2023-02625
• Device Sequence Number: 14125970
• Product Code: NKB
• UDI-Device Identifier: 10705034077437
• UDI-Public: (01)10705034077437
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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,Followup

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 Catalogue Number: 179762480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/19/2024
• 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 - LOCKING/SET SCREWS: EXPEDIUM SFX; UNK - SCREW/ROD ACCESS: EXPEDM SFX CROSSCONNECTOR; UNK - SCREWS: PEDICLE; UNK - SCREWS: VIPER SAI; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female