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

Catalog Number 186731645

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Type  Injury  

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.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 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 9 of 10 for complaint (b)(4).

• Brand Name: 5.5 TI CORT FIX 6X45MM
• Type of Device: 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: 18476667
• MDR Text Key: 332492151
• Report Number: 1526439-2024-00538
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034351834
• UDI-Public: (01)10705034351834
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 186731645
• Device Lot Number: 179886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• 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
• Treatment: 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
• Patient Outcome(s): Required Intervention