MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	186731645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
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.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: mni, mnh, kwp, 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
Device report from synthes reports an event in japan as follows: it was reported that this was an unknown surgery on (b)(6) 2018.After the surgery, the extended re-fusion surgery will be performed due to the adjacent intervertebral disorders.It is confirmed l4/5 achieved osteosynthesis.The revision surgery was performed on (b)(6) 2023.The set screws, rods and the crosslinks were removed.Plif was performed on l1/2, and tlif was performed on l2/3 and extended.L1:expedium diameter5.0-40×2.L2 left: diameter5.0-45 right diameter6.0-45.L2/3:cageconcorde h8×w9×l23×angle5.Crosslink: a4 anda5.L1-l5: rod connection.Remarks: (b)(4) are involved with the same event.(b)(4) (depuy spine): screws.(b)(4) (synthes spine): cages.This report is for one (1) 5.5 ti cort fix 6x45mm.This is report 8 of 10 for complaint (b)(4).

• Brand Name: 5.5 TI CORT FIX 6X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE 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: 18476632
• Report Number: 1526439-2024-00536
• Device Sequence Number: 12364056
• Product Code: NKB
• UDI-Device Identifier: 10705034351834
• UDI-Public: (01)10705034351834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 186731645
• Device Lot Number: 198330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/09/2024
• 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: 5.5 TI CORT FIX 7X40MM; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown