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

Model Number	2968250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation is not possible as device remains implanted in patient.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of lumbar spinal canal stenosis.There was no delay in overall procedure time as a result of this event.There were patient symptoms or complications as a result of this event.Device remains implanted in patient.The patient who received olif on l4/5 and posterior pps fixation with sextant last time was performed re-operation this time on (b)(6) 2020 due to stenosis between l2/3 and l3/4.There was posterior decompression, so plif was selected this time.Decompression was performed on l2/3 only.Plif was performed on l3/4.Bone fusion has been achieved on l4/5, so finally fixation was performed with rod on l3/4.Previous disease is ht lumbar spinal canal stenosis and lumbar degenerative spondylolisthesis.

• 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 ; DE 94469
• MDR Report Key: 10349109
• Report Number: 1030489-2020-01013
• Device Sequence Number: 2398627
• Product Code: MAX
• UDI-Device Identifier: 00613994485809
• UDI-Public: 00613994485809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: 03/31/2022
• Device Model Number: 2968250
• Device Catalogue Number: 2968250
• Device Lot Number: YU02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/31/2020
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 71