MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BULLET SPINAL SYSTEM LORDOTIC IMPLANT 9 X 8 X 27MM, 5 DEGREES; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	187827408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from malaysia reports an event as follows: it was reported that during a procedure on 26-october-2023, the concorde bullet in question had its corner break off during implantation.During the implantation process, the back corner broke off while being impacted into the patient body using a mallet.The broken implant was removed and replaced with a new implant.All generated fragments were removed without additional medical intervention.The procedure was completed successfully with 10 minutes of surgical delay.There was no reported adverse patient impact.No further information is available to report.This report is for a concorde bullet spinal system lordotic implant 9 x 8 x 27mm, 5 degrees.This is report 1 of 1 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.H10 additional narrative: d2: additional procode: mqp.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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.The photo investigation revealed that the concorde bul lor 9x8x27, 5 dg was broken.The broken fragment is not visible in the photo.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed for concorde bul lor 9x8x27, 5 dg.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 LORDOTIC IMPLANT 9 X 8 X 27MM, 5 DEGREES
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 18140895
• Report Number: 1526439-2023-02341
• Device Sequence Number: 20844550
• Product Code: MAX
• UDI-Device Identifier: 10705034140056
• UDI-Public: (01)10705034140056
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K173787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup

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: 187827408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 11/29/2023
• 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: CONCORDE INSERTER-BAYONET
• Patient Age: 64 YR
• Patient Sex: Male