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

Catalog Number	4986845
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2020
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
It was reported that the patient presented with spinal stenosis; and underwent anterior interbody fusion and oblique lumbar interbody fusion at l3-l5.Intra-op, the cage broke while its position was being adjusted.When checking the image after cage placement, it was found that the cage had advanced too much (from the position expected by the surgeon) to the contralateral side.Therefore, the position of the cage was being adjusted by hammering the inserter handle upward from the bottom while the cage was gripped by the inserter.Although the cage position could be adjusted, it was noticed when the inserter was removed that about 5mm of the cage was broken.The cage was broken in the way that the gripping part of the cage was still held by the inserter.The remaining portion of the cage was placed in a good position and there were not many broken parts; so, the cage was left implanted inside the patient¿s body according to the judgement of the surgeon.No patient complications were reported as a result of this event.It was said that the cage breakage was due to hammering the inserter in the upward direction.It was considered that the inserter swayed to the cranial and caudal side, and strong force was applied to the connection part of the cage and the inserter, which made the cage break.Fragments of the cage were discarded and the inserter was not broken.

• 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: 10027755
• Report Number: 1030489-2020-00502
• Device Sequence Number: 10956631
• Product Code: MAX
• UDI-Device Identifier: 00643169190535
• UDI-Public: 00643169190535
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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 Catalogue Number: 4986845
• Device Lot Number: H5514670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1