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	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not 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-op diagnosis: posterior scoliosis procedure: oblique lumbar interbody fusion(olif), lateral lumbar interbody fusion(xlif) levels: l2/3/4/5 it was reported that during surgery, the cage was allegedly reported broken.After the cage was inserted using an inserter that has sleeves, the cage was removed using a remover to adjust its position.When the cage was attached to the inserter to reinsert, the force grasping the cage was found to be weak.The cage was replaced.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: the threads on the backside of the implant have been stripped out.Witness marks on the backside of the implant indicate the implant was tightened fully.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: 7163222
• Report Number: 1030489-2018-00009
• Device Sequence Number: 13827273
• 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: 2017
• 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): 04/18/2018

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: 11/23/2023
• Device Catalogue Number: 4922045
• Device Lot Number: 35AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR