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

Model Number	2968250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from other, healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis for lumbar stenosis.Procedure or therapy performed was olif therapy.Levels implanted 3-5.It was reported that the proximal end of the cage was broken.There were no symptoms reported.There were no further complications reported regarding the event.Cage was broken during the implantation.No additional surgery required at the moment.The remaining cage is inside the patient.The small piece that was broken it's outside the patient.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLYDESDALE¿ 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: 14267064
• Report Number: 1030489-2022-00425
• Device Sequence Number: 5843100
• Product Code: MAX
• UDI-Device Identifier: 00613994485809
• UDI-Public: 00613994485809
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K083026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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: 2968250
• Device Catalogue Number: 2968250
• Device Lot Number: 21LS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/03/2022
• Date Device Manufactured: 05/18/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 100 KG