MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CONCORDE LIFT CAGE; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	183656014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
It was reported that on (b)(6) 2020, while surgeon inserted an concorde proti 360 tlif cage and the cage snapped in half.Surgeon was able to retrieve the cage with minimal delay.Procedure was successfully completed with approximately 5-10 minutes surgical delay.There were no patient consequences.Concomitant device reported: unknown inserter (part# unknown, lot# unknown).This complaint involves one (1) device.This report is for (1) eagle+/swift+ scr, prm, st, 14.This is report 1 of 1 for (b)(4).
Event or Problem Description
Update: eagle+/swift+ scr, prm, st, 14 was updated to unknown 8x9x23 concorde proti 360 tlif cage as stated by the original event description.
Additional Manufacturer Narrative
Product complaint #(b)(4).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: b5: updated information provided for reporting.D11: additional concomitant product added to complaint.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.H11: d1: brand name updated d4: catalog updated 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: UNKNOWN CONCORDE LIFT CAGE
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10656791
• Report Number: 1526439-2020-01919
• Device Sequence Number: 2767229
• Product Code: KWQ
• UDI-Device Identifier: 10705034095974
• UDI-Public: 10705034095974
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K070994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 183656014
• Device Catalogue Number: UNK CONCORDE LIFT CAGE
• Device Lot Number: 151840
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTER; UNKNOWN INSERTER; UNKNOWN CAGE/SPACER; UNKNOWN INSERTER
• Patient Age: 65 YR