MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 10MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number PDL-M-PT10S

Device Problem Expulsion (2933)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Information provided by the reporter indicates that a patient came to a surgeon for routine follow up approximately 1.5 years after implantation.The surgeon ordered x-ray imaging of the patient's prodisc l implant at l5-s1.The imaging revealed the prodisc l pe inlay has expelled from the inferior endplate.An image of this malfunction was provided to centinel spine to confirm the alleged complaint.The patient did not have any signs or symptoms related to the device malfunction at the time of this complaint.The surgeon plans to revise the patient, but no surgery date has been scheduled.This malfunction is likely to lead to serious injury or medical intervention thus a report was required.Dhr review could not be completed as part and lot numbers were not provided.Traceability to the specific patient involved was not provided despite attempts to gather additional information.The rate of complaints was determined to be acceptable based on the design fmea for prodisc l.All associated risks were identified, mitigated, and determined to be acceptable.There is no indication of a new risk as a result of this complaint.The device remains implanted in the patient thus is not available for evaluation.This submission is for the polyethylene inlay (1 of 3 devices involved).

Event Description

A patient came into the surgeon for a routine follow up approximately 1.5 years after implantation on an unknown date.The surgeon ordered x-ray images on an unknown date.The images revealed the patient's pdl implant at l5s-1 had an inlay expulsion.The inlay expulsion is likely to lead to surgical intervention to preclude serious injury based on previous complaints.The distributor rep indicated the patient was experiencing no symptoms or complications as a result of the malfunction.

Manufacturer Narrative

Information provided by the reporter indicates that a patient came to a surgeon for routine follow up approximately 1.5 years after implantation.The surgeon ordered x-ray imaging of the patient's prodisc l implant at l5-s1.The imaging revealed the prodisc l pe inlay has expelled from the inferior endplate.An image of this malfunction was provided to centinel spine to confirm the alleged complaint.The patient did not have any signs or symptoms related to the device malfunction at the time it was identified.The surgeon initially planned to revise the surgeon, and has since revised the patient to an alif fusion using a synfix cage.The removal and replacement of the prodisc l devices was completed without issue.Additional prognosis for the patient was not provided.According to the reporter, the patient was still not showing any symptoms or complications related to the malfunction at the time of revision.Dhr review was performed and no manufacturing problems were noted.The rate of complaints was determined to be acceptable based on the design fmea for prodisc l.All associated risks were identified, mitigated, and determined to be acceptable.There is no indication of a new risk as a result of this complaint.The patient requested they keep the explanted device.This follow up submission is for the inferior endplate (1 of 3 devices involved).

Event Description

Updated information: patient underwent a revision surgery to remove the prodisc l implants and replace them with an alif synfix fusion cage.The deves were explanted and replace without issue.At the time of the revision procedure, the patient was still indicated to not be showing any signs or complications related to the malfunction.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 10MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 10685503
• MDR Text Key: 219553127
• Report Number: 3007494564-2020-00046
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: PDL-M-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: H548037
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR