MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	179702000S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, an exp 5.5 revision surgery took place at the hospital.During this surgery it was discovered that all eight exp innies were loose.The revision surgery took place because the patient had an infection and the screws became loose.Surgery was not delayed the procedure was completed successfully.No fragments were generated.This report is for a single-inner setscrew this is report 1 of 10 for (b)(4).(b)(4) is related to this (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: b3: unknown date when infection started/screws moved e3: reporter is a j&j employee.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: SINGLE-INNER SETSCREW
• Common Device Name: FIXATION, SPINAL INTERVERTEBRAL BODY
• 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 ; SZ ; 3035526892
• MDR Report Key: 19341190
• Report Number: 1526439-2024-01519
• Device Sequence Number: 7162641
• Product Code: NKB
• UDI-Device Identifier: 10705034265063
• UDI-Public: (01)10705034265063
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K200245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/16/2024

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: 179702000S
• 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: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNK - RODS: EXPEDIUM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown