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

Catalog Number	4986255
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse events: other - pain and suspected infection.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 underwent oblique lateral interbody fusion (olif) surgery at l3/4/5 due to dish (diffuse idiopathic skeletal hyperostosis) patient and restenosis after posterior decompression.Two weeks later, the patient was hospitalized for the schedule of posterior fixation, but the patient complained of pain and was diagnosed by magnetic resonance imaging (mri).Cleaning was performed due to the suspected infection.When the cage of l3/4 was touched, it was found to be unsteady, so removal was also performed.Cleaning was performed repeatedly and the wound was closed.It seemed that icu management was necessary after surgery and the patient was transferred to another hospital while being intubated.

• 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: 9761391
• Report Number: 1030489-2020-00228
• Device Sequence Number: 16772278
• Product Code: MAX
• UDI-Device Identifier: 00643169190665
• UDI-Public: 00643169190665
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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 Expiration Date: 06/15/2025
• Device Catalogue Number: 4986255
• Device Lot Number: H5341140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention