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

Catalog Number	4922045
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/04/2018
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
Procedure: oblique lumbar interbody fusion (olif) levels implanted: l3-l4 it was reported that the patient presented with kyphoscoliosis.Post-op, revision surgery was performed for hammering the cage again as the cage at l3-l4 backed out.On (b)(6) 2018, fusion was also performed at t10-s2.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7739498
• Report Number: 1030489-2018-01087
• Device Sequence Number: 16413074
• Product Code: MAX
• UDI-Device Identifier: 00643169190801
• UDI-Public: 00643169190801
• 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,Followup
• Report Date (Section B): 10/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2023
• Device Catalogue Number: 4922045
• Device Lot Number: 35AF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: Required Intervention
• Patient Age: 70 YR