MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CLYDESDALE PTC SPINAL SYSTEM

Catalog Number	4986855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
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 presented with spinal canal stenosis; and underwent oblique lumbar interbody fusion at l2-l3.Intra-op, after cage insertion, a marker was found near the retractor.It was confirmed to be a fragment of the cage, which was retrieved inside the operative field and was discarded in the facility.The intervertebral disc space was narrow and the bone was also hard due to which there was resistance during cage insertion.So, cage insertion was performed by strong hammering.No operations such as twisting have been performed.There was a delay of less than 60 minutes in overall procedure as a result of this event; but no patient complications were reported.The surgeon was not sure whether this event occurred because the bone was hard.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9737520
• Report Number: 1030489-2020-00184
• Device Sequence Number: 1802226
• Product Code: MAX
• UDI-Device Identifier: 00643169190511
• UDI-Public: 00643169190511
• 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): 02/21/2020

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: 4986855
• Device Lot Number: H5537113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 78