MAUDE Adverse Event Report: DEPUY SPINE INC STAPLE, 20 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	172802020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021 the surgeon and surgical team performed several procedures including an anterior lumbar interbody fusion and bone graft.All procedures were performed pursuant to the standard of care, with no deviation from the surgical steps.These procedures included the implantation of the depuy products.On (b)(6) 2021 the surgeon and surgical team performed several procedures including revision procedures, osteotomy procedures, and removal of hardware.During the spine procedure the surgeon cut the depuy transition rods between the c6 and t1 spinal levels.The cervical portion of these were removed.The set caps were removed.Lateral mass screws at c4-c5 and c6 were removed.The surgeon also observed that the fusion mass around c3-4 was weak and was easily spread apart.The surgeon then implanted cervical rods with connectors to the t1 level.These procedures included the implantation of the depuy products.This report is for one (1) staple, 20 mm.This is report 2 of 4 for complaint (b)(4).
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a legal attorney.H3, h4, h6: without a lot number the device history records review could not be completed.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.

• Brand Name: STAPLE, 20 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 20081248
• Report Number: 1526439-2024-02176
• Device Sequence Number: 12678453
• Product Code: KWQ
• UDI-Device Identifier: 10705034015644
• UDI-Public: (01)10705034015644
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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 Catalogue Number: 172802020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ANTI BACKOUT SCREW, 25 MM.; ANTI BACKOUT SCREW, 30 MM.; STAPLE, 24 MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female