MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 8 X 23MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 187823108

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

Device report from japan reports an event as follows: the patient had a posterior lumbar interbody fusion (l4/5) performed on (b)(6) 2014.At an unknown date after the surgery, asd occurred.It was reported that on (b)(6) 2023, a revision procedure was performed to extend fixation.- olif was performed in l2/3 and l3/4 in side lying position.- a positional change to prone and removal of existing 4/5 crosslink, set screw and rod.- plif for l5/s (using non-depuy synthes product).- verse screw insertion at l2 (diameter 6.0 - length 45mm), verse screw insertion at l3 (diameter 7.0 - 45mm).- expedium-cfs insertion in s1 (diameter 7.0 - length 40mm), expedium-cfs insertion in s2 aller (diameter 7.0 - 40mm).- osteotomy rod installation set screw correction.- bone graft final tightening.- cross-link installation.The revision procedure was completed successfully with no adverse patient impact.No further information is available.This report is for a concorde bullet spinal system parallel 9 x 8 x 23mm.This is report 2 of 4 for (b)(4).

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.: d2: additional procode: max.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.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.

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: h4, h6: a review of the receiving inspection (ri) for concorde bul par 9x8x23, was conducted identifying that lot number apcfn0 was released in one batch.Batch1: lot units were released on 13 may 2013 with no discrepancies.Supplier : medos int spine.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 8 X 23MM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 18049944
• MDR Text Key: 327128789
• Report Number: 1526439-2023-02166
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10705034139333
• UDI-Public: (01)10705034139333
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173787
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 187823108
• Device Lot Number: APCFN0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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 6X45MM.; 5.5 TI CORT FIX 6X45MM.; CONCORDE BUL PAR 9X8X23.
• Patient Outcome(s): Required Intervention