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

Catalog Number	4986850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Injury (2348)
Date of Event	08/23/2018
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
It was reported that the patient was pre-operatively diagnosed with lumbar spinal canal stenosis and underwent anterior lumbar fusion at l2/3.During surgery, oblique lumbar interbody fusion was performed until th12/l3.When closing the wound, the cage which was inserted at l2/3 deviated to the ventral side and the anterior longitudinal ligament was injured.For recovery, it was attempted to insert the cage to dorsal side.So the product was tried to be inserted again in another direction, but the direction could not fit well.Hence cage insertion was given up and the cage was replaced with autogenous bone.There was a delay of less than 60 minutes in the overall procedure.Product came in contact with patient.Paralysis occurred to patient.

• 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: 7900059
• Report Number: 1030489-2018-01276
• Device Sequence Number: 1706855
• Product Code: MAX
• UDI-Device Identifier: 00643169190528
• UDI-Public: 00643169190528
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 12/02/2024
• Device Catalogue Number: 4986850
• Device Lot Number: 21CZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/21/2018
• 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