MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	4986240
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
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
Pre-operative diagnosis: lumbar spinal canal stenosis procedure used: oblique lumbar interbody fusion it was reported that intra-op, after the cage was inserted, the l2 superior endplate collapsed.The physician confirmed collapse by the intra-operative perspective image on the spot.No additional surgery was performed.The cage came in contact with the patient and did not break.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7921654
• Report Number: 1030489-2018-01314
• Device Sequence Number: 13904966
• Product Code: MAX
• UDI-Device Identifier: 00643169190696
• UDI-Public: 00643169190696
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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 Expiration Date: 08/23/2024
• Device Catalogue Number: 4986240
• Device Lot Number: 25CL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other