MAUDE Adverse Event Report: DEPUY SPINE INC CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 7 X 23MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	187823107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: max.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6) hospital.Initial reporter occupation: reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 japan as follows: it was reported that the patient underwent a plif on (b)(6) 2018.The surgery was completed successfully without any delay.On (b)(6) 2022, an extension to the upper vertebral body revision plif was scheduled to be performed because the patient developed an adjacent intervertebral disorder.No further information is available.This report involves one concorde bullet spinal system parallel 9 x 7 x 23mm.This is report 11 of 12 for (b)(4).

• Brand Name: CONCORDE BULLET SPINAL SYSTEM PARALLEL 9 X 7 X 23MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16078338
• Report Number: 1526439-2022-02241
• Device Sequence Number: 6159986
• Product Code: MQP
• UDI-Device Identifier: 10705034139326
• UDI-Public: 10705034139326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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

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: 187823107
• Device Catalogue Number: 187823107
• Device Lot Number: ANJCH7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 12/30/2022
• 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: 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X50MM; 5.5 TI CORT FIX 7X50MM; CONCORDE BUL PAR 9X7X23; MMSI ROD, 5.5 X 40MM, TI; MMSI ROD, 5.5 X 40MM, TI; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown