MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L INFERIOR ENDPLATE, MEDIUM, 0, STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-IP00S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by the reporter indicates the patient was implanted with a prodisc l at l5/s1.During routine follow up imaging, it was noted the superior endplate subsided into the l5 vertebrae.The patient was not experiencing any symptoms or complications.The surgeon performed a revision/secondary surgery to add posterior mis pedicle screws across l5/s1.This information led to a conservative determination that the complaint was a reportable event.Dhr review did not find any problems which may have contributed to the reported complaint.Complaint history indicates this is the 1st indication of prodisc l subsidence during the review period.The rate of complaints was determined to be acceptable based on the risk assessment.Subsidence and loss of motion were identified as hazardous situations which could lead to patient harm.No device evaluation was performed as the device was left implanted.Review of the prodisc l us surgical technique guide and imaging provided suggest the implant size selected is undersized for this patient.The surgical technique guide suggests the largest possible implant footprint should be used to maximize the endplate contact.This observation was made comparing the vertebral body size versus the size of the implant.A large footprint implant could have been used to increase endplate contact.Additionally the surgeon was unable to properly trial a 10mm height implant and instead placed a 12mm height implant.This may have caused/contributed to the implant subsidence.This submission is for 1 of 3 devices involved in this event.
Event or Problem Description
A patient received a prodisc l medium 12mm implant on (b)(6) 2021 within the l5/s1 disc space.After implantation on (b)(6) 2021, follow up imaging indicated the superior endplate subsided into the l5 vertebrae.The patient was not reporting any complications or symptoms.The surgeon chose to perform a revision/second surgery to add posterior mis pedicle screws across l5/s1.The second surgery was performed on (b)(6) 2021 to control the subsidence.The prodisc l implant was left implanted.There was no other patient comorbidities.

• Brand Name: PRODISC L INFERIOR ENDPLATE, MEDIUM, 0, STERILE
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 12407345
• Report Number: 3007494564-2021-00076
• Device Sequence Number: 11809951
• Product Code: MJO
• UDI-Device Identifier: 00843193111753
• UDI-Public: 00843193111753
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: PDL-M-IP00S
• Device Catalogue Number: N/A
• Device Lot Number: 2020-0741
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/01/2021
• 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: Required Intervention
• Patient Age: 45 YR