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

Catalog Number	4922255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
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
Pre-operative diagnosis for this procedure: lumbar spinal canal stenosis type of procedure or technique used: anterior lumbar fusion and posterior lumbar fusion it was reported that intra-op, thread of the cage was deformed or broken.Intra-operatively, after cleaning up the intervertebral disc, when about 90% of the cage was inserted at l4-5, it was difficult to insert the cage deeper.The physician tried to hit the inserter to contralateral side with a hammer in order to remove the cage, however it could not be removed.The cage was then removed by removal implement and the intervertebral disc was curetted again.When trying to attach the cage to the inserter again, the cage could not be gripped due to probable breakage of thread of the cage.A new cage was then opened to deal with this problem.There were no patient symptoms or complications as a result of this event.

• Brand Name: CLYDESDALE PTC 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: 7948896
• Report Number: 1030489-2018-01340
• Device Sequence Number: 1514734
• Product Code: MAX
• UDI-Device Identifier: 00643169191310
• UDI-Public: 00643169191310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 02/27/2026
• Device Catalogue Number: 4922255
• Device Lot Number: 68FA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1