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

Model Number	187827107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Tissue Damage (2104); Not Applicable (3189)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
In the application of the lumbar concorde bullet box, the sales representative did not inform the dr.Exactly the characteristics of the product, assuming that he already knew the product and he did not previously ask about it.At the time of insertion, the specialist did not understand the specifications (it was informed by sales rep) impacting the device until the anterior part of the vertebrae l4 and l5, which could not be recovered and he had to leave it in a free cavity and apply another implant for the function that was required.The specialist introduced the implant under radiological vision and still has too much impact.The dr was not bothered at any time, but in the surgical description he argued that the instrumenter of the house told him the manufacturer's specifications for insertion, clearing his name of any legal circumstance.Patient consequence? :yes.Patient condition description: the device is left in the anterior part of the vertebral body.Action taken for procedure: it was tried to recover the implant, but it was impossible.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.Product information: code: 187827107 and lot: atmfr3.

• Brand Name: CONCORDE BUL PAR 9X7X27
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• MDR Report Key: 7379010
• Report Number: 1526439-2018-50274
• Device Sequence Number: 882817
• Product Code: MAX
• UDI-Device Identifier: 10705034139883
• UDI-Public: (01)10705034139883
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K041722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 187827107
• Device Catalogue Number: 187827107
• Device Lot Number: ATMFR3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 85