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

Catalog Number	2968255
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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.
Event or Problem Description
It was reported that the patient underwent oblique lumbar interbody fusion (olif) procedure due to lumbar degeneration.Intra-op, the doctor found that the implanted cage was fractured.The cage was replaced with a new one.No patient complications were reported as a result of this event.No fragments of the broken product remained inside the patient.
Additional Manufacturer Narrative
Product analysis result: visual microscopic the cage was returned cracked into multiple pieces.A microscopic review of the fracture face is consistent with material overload during impaction.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, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 7288244
• Report Number: 1030489-2018-00258
• Device Sequence Number: 2379247
• Product Code: MAX
• UDI-Device Identifier: 00613994485793
• UDI-Public: 00613994485793
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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: 10/19/2025
• Device Catalogue Number: 2968255
• Device Lot Number: 12ES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR