MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BUL PAR 9X7X27; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187827107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
9x7x27mm concorde bullet cage broke while implanting.Patient consequence?: yes.Patient consequence description:broken pieces left in patient.Could not be removed.Action taken for procedure:broken pieces of cage were extracted.The tip of the bullet cage remained in patient as it could not be removed.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

• Brand Name: CONCORDE BUL PAR 9X7X27
• 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
• MDR Report Key: 7784572
• Report Number: 1526439-2018-50793
• Device Sequence Number: 1678380
• Product Code: MAX
• UDI-Device Identifier: 10705034139883
• UDI-Public: (01)10705034139883
• Combination Product (Y/N): N
• PMA/510(K) Number: K041722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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 Model Number: 187827107
• Device Catalogue Number: 187827107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 50 YR