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

Catalog Number	4986850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
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
Type of procedure or technique used : lumbar anteroposterior fusion levels implanted: l3/4/5 it was reported that the patient presented with degenerative scoliosis, spinal canal stenosis.Intra-op, the cage was broken when gripping the high part of cage to remove it with slap hammer.The cage could not be removed any more.Dd was indwelt in the position and the operation was completed.The product came in contact with the patient.No patient symptoms or complications were reported as a result of this event.Half of the implant was left in patient.
Additional Manufacturer Narrative
Product analysis:the device was returned fractured and missing the "nose" portion of the implant.The threaded hole on the back of the implant has been stripped and there are witness marks consistent with the inserter being hammered during implantation.There are witness marks from the implant being removed with what appears to be pliers.The fracture appears to have occurred during a bending moment during the removal process.If there is not enough free space for the cage to be installed the cage can become stuck.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: 7650010
• Report Number: 1030489-2018-00936
• Device Sequence Number: 19287124
• Product Code: MAX
• UDI-Device Identifier: 00643169190528
• UDI-Public: 00643169190528
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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: 04/24/2025
• Device Catalogue Number: 4986850
• Device Lot Number: H5343929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 66