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

Catalog Number	2968045
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the patient with lumbar canal stenosis underwent anterior and posterior interbody fusion surgery, in which, cage, screws and rods were implanted at l4-5.Post-op, the patient underwent revision surgery due to migration of the cage inside the patient.In this surgery, the cage, screws and rods were explanted.The migrated cage was replaced with a new cage in this surgery.It was also reported that there was a possibility of infection in the patient due to this event.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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: 6325063
• Report Number: 1030489-2017-00295
• Device Sequence Number: 694935
• Product Code: MAX
• UDI-Device Identifier: 00613994485861
• UDI-Public: 00613994485861
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2968045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RODS, SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 47