MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	4986245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
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
It was reported that the patient underwent oblique lumbar interbody fusion - olif at l3/4, l4/5.Intra-op, during hammering with grasping the shaft part below the nut of the inserter, a glove was caught in, and the shaft could not move.The inserter was removed once, and the cage was removed, but the shaft still could not move.Another inserter was used, but because the thread of the cage was broken and it could not be grasped, a new one was unpacked.A scrub nurse made the shaft move with using a remover and the glove which was caught in was removed.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis result: visual microscopic visual microscopic examination of the implant identified asymmetrical witness mark on the top face of the implant and stripped internal threads in the center threaded hole.These observations are consistent with significant impact during attempted implantation.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7628301
• Report Number: 1030489-2018-00891
• Device Sequence Number: 1940275
• Product Code: MAX
• UDI-Device Identifier: 00643169190689
• UDI-Public: 00643169190689
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: 11/07/2025
• Device Catalogue Number: 4986245
• Device Lot Number: H5378890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1