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

Model Number	2968050
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with oblique lateral interbody fusion therapy.It was reported that the implant was pull out.There were no symptoms reported.There were no further complications reported regarding the event.

• Brand Name: CLYDESDALE 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: 11490664
• Report Number: 1030489-2021-00346
• Device Sequence Number: 11726958
• Product Code: MAX
• UDI-Device Identifier: 00613994485854
• UDI-Public: 00613994485854
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K083026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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 Model Number: 2968050
• Device Catalogue Number: 2968050
• Device Lot Number: H5592637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR