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

Model Number	3992207
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other: rupture of intervertebral disc space.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 'lcd'; and underwent posterior lumbar interbody fusion at l3-l5.Intra-op, the threaded part of the cage, which was used to connect with the inserter, stripped and the cage could not be attached to the inserter.When the cage was hammered in, the cage did not enter the intervertebral disc space fully, and the threaded part loosened.The cage was taken out and an attempt was made to attach the cage to the inserter again outside the operative field, but the threaded part was found widened and the cage could not be attached to the inserter.The cage was replaced with a new cage, but the new cage was placed as if it was pushed in forcibly.Since the images and radiographs were not checked during operation, it was checked after the operation, which found that the tip of the screw may have ruptured into the intervertebral disc space.There was a delay of less than 60 minutes in overall procedure time as a result of this event.No fragment of the stripped implant remained inside the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H3.Device evaluation summary: after visual and optical examination, it appears that the spacer was returned having fractured at the tip and deformation of the two inserter locating tabs.The fracture emanates from the bottom of the locating tabs and traveled to the outer edge of the spacer.This type of fracture is consistent with compression overload during implantation, that can be the result of the spacer not having a lager enough open area to be installed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE 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: 9934298
• Report Number: 1030489-2020-00430
• Device Sequence Number: 16332327
• Product Code: MAX
• UDI-Device Identifier: 00643169187566
• UDI-Public: 00643169187566
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3992207
• Device Catalogue Number: 3992207
• Device Lot Number: H5507637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREW, INSERTER
• Outcome Attributed to Adverse Event: Other