MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 12MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number PDL-M-PT12S

Device Problem Osseointegration Problem (3003)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2024

Event Type  Injury  

Event Description

A patient was implanted with prodisc l on (b)(6) 2024 at level l4-5.Within 12 hours the implant had subsided into the vertebrae.The pdl implant was removed and the patient was revised to an alif on (b)(6) 2024.

Manufacturer Narrative

An mdr is indicated for this complaint.A patient was implanted with prodisc l on (b)(6) 2024 at level l4-5.Within 12 hours the implant had subsided into the vertebrae.The pdl implant was removed and the patient was revised to an alif on (b)(6) 2024.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the levels defined in the risk documentation.A review of the risk documentation found that the risks associated with the complaint are identified and mitigated to a level where the clinical benefits of surgery outweigh the risks.Device evaluation could not be completed as the implant was not returned following the removal surgery.There were no anomalies associated with the complaint identified during the complaint investigation.The reason for the implant removal is subsidence.The submission is 2 of 3 devices involved in this event.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 12MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer (Section G): FRUH VERPACKUNGSTECHNIK AG; allmendstrasse 47; fehraltorf, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 18950148
• MDR Text Key: 338249589
• Report Number: 3007494564-2024-00028
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193111777
• UDI-Public: 00843193111777
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDL-M-PT12S
• Device Catalogue Number: N/A
• Device Lot Number: 2020-1151
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2020
• 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: 54 YR
• Patient Sex: Male