MAUDE Adverse Event Report: DEPUY SPINE INC CONCORDE BUL PAR 9X7X23; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187823107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: additional product code: mqp.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 conclusion could be drawn at the time of filing this report.The 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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent a surgery for plif.During the surgery, the cage was broke due to a limited interbody space when the cage was tapped with a hammer.The surgery was completed without delay.No further information is available.Concomitant device reported: unknown hammer (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) concorde bul par 9x7x23.This report is 1 of 1 for (b)(4).

• Brand Name: CONCORDE BUL PAR 9X7X23
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12314230
• Report Number: 1526439-2021-01673
• Device Sequence Number: 19979874
• Product Code: MAX
• UDI-Device Identifier: 10705034139326
• UDI-Public: 10705034139326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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: 187823107
• Device Catalogue Number: 187823107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/12/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCORDE BUL PAR 9X7X23