MAUDE Adverse Event Report: MSD DEGGENDORF MFG CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	4922255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having direct lateral interbody fusion (dlif) approach.It was reported that the device was damaged. while the surgeon was implanting the product, we noticed the inserter/implant made a distinct noise.After looking at the xray, we notice the inserter was bent and the implant was damaged.So, we are not sure if the implant caused the inserter to bend or if the inserter bending caused the implant to break.The mallets were broken.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that it was a failure on the inserter prongs that created the breakage/failure on the implant.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: product analysis product id (b)(4); lot# 90bx a visual review of the returned implant identified that portions have been broken.Microscopic examination of the inserter interface identified damage to the threaded hole area and deformation on the top face, and fracture on one side around the inserter tang interface, consistent with significant impact and torsional loading.Microscopic examination of the fracture surface of the broken portions of the implant identified a fracture with rays emanating away from the area of crack initiation, consistent with brittle overload.The observations are consistent with impaction overload.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19132219
• Report Number: 1030489-2024-00292
• Device Sequence Number: 15166941
• Product Code: MAX
• UDI-Device Identifier: 00643169191310
• UDI-Public: 00643169191310
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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 Expiration Date: 06/23/2024
• Device Model Number: 4922255
• Device Catalogue Number: 4922255
• Device Lot Number: 90BX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Unknown