MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DUAL-INNER SETSCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	179722000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
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.H10 additional narrative: 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 or Problem Description
It was reported that the patient underwent a removal of hardware due to infection on (b(6) 2024.Four screws, 3 lateral connectors, and 7 set screws were removed.This report involves one exp dual-inner setscrew for (b)(4).Additional impacted products related to this event are captured in (b)(4).Additionally, (b)(4) captures an instrument malfunction that occurred during the removal surgery.

• Brand Name: EXP DUAL-INNER SETSCREW
• 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 ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19286186
• Report Number: 1526439-2024-01434
• Device Sequence Number: 12852130
• Product Code: NKB
• UDI-Device Identifier: 10705034070070
• UDI-Public: (01)10705034070070
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• 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 Catalogue Number: 179722000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/10/2024
• 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: DI POLYAXL SCREW 8 X 65MM; DI POLYAXL SCREW 8 X 80MM; EXP DUAL-INNER SETSCREW; EXP DUAL-INNER SETSCREW; LATERAL CONNECTOR, 20MM; LATERAL CONNECTOR, 50MM; LATERAL CONNECTOR, 50MM; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; SI POLYAXL SCREW 7 X 40MM; SI POLYAXL SCREW 7 X 40MM; UNK - RODS: EXPEDIUM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown