MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number	179771555
Medical Device Problem Codes	Device Slipped (1584); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023 the initial surgery was performed via posterior fusion.In the surgery, the screws were inserted t10-l5, and fusion was performed with the hooks.After the initial surgery, the screws and hooks on l4 and l5 were loosened via posterior fusion on (b)(6) 2024.In the surgery, the surgeon cut the rod between l3 and l4 internally and did not deploy cephalad of l3.The screws in l4 and l5 were replaced, and after insertion of s1 and s2ai screws, the rods were connected at l4-s2ai.He attached the universal connector in question to the rod of the cut l3 section and another universal connector in question between the l5 and s screws, connecting the upper and lower sections with the rod.The surgery was completed successfully.On (b)(6) 2024, the sales rep was informed that the universal connectors were disconnected.No further information is available.This report is for an expedium spine system side loading open/open top notch connector 5.5 x 5.5mm.This is report 1 of 2 for (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: d2: additional procodes: kwp, kwq, osh, nkb, mni d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes 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.

• Brand Name: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• 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: 18711149
• Report Number: 1526439-2024-00898
• Device Sequence Number: 8201090
• Product Code: MNH
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• 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: 2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 179771555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2024
• Initial Report FDA Received Date: 02/15/2024
• 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: CONN O/O SD TOP NTCH 5.5X5.5 T; UNKNOWN RODS
• Patient Sex: Unknown