MAUDE Adverse Event Report: CENTINEL SPINE 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 Insufficient Information (4580)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was implanted with two prodisc l devices at l4/l5 and l5/s1 on (b)(6) 2021.It was found that the poly inlay had expulsed anteriorly from the endplates at the l5/s1 level.The surgeon performed a pdl removal of that level on (b)(6) 2023.Patient was then fused using a cage and posterior pedicle screws.A review of the associated dhrs found no anomalies related to the complaint.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazard associated with this complaint is identified and mitigated to a level where the benefits outweigh the risks.Device evaluation will be completed by exponent under pdl-rd-0008 using their standard pdl evaluation procedure.It was confirmed that a revision took place due to poly inlay expulsion.No other anomalies associated with the complaint were found during the investigation.This report is for 2 of 3 devices in this event.

Event Description

A patient was implanted with two prodisc l devices at l4/l5 and l5/s1 on (b)(6) 2021.It was found that the poly inlay had expulsed anteriorly from the endplates at the l5/s1 level.The surgeon performed a pdl removal of that level on (b)(6) 2023.Patient was then fused using a cage and posterior pedicle screws.

Event Description

Update to add udi number to report.

• 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; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): HAMMILL MANUFACTURING COMPANY; 360 tomahawk drive; maumee OH 43537
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 16690090
• MDR Text Key: 312787008
• Report Number: 3007494564-2023-00017
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193111760
• UDI-Public: 00843193111760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDL-M-PT10S
• Device Lot Number: 2020-1450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male