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

Model Number PDL-L-PT10S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Multiple Fractures (4519)

Event Date 02/29/2024

Event Type  Injury  

Event Description

Patient was implanted with a prodisc l device at the l5/s1 level on (b)(6) 2023.Following the implantation surgery, the patient was found to have bilateral pars fractures at the index level.The patient is not experiencing any symptoms.The surgeon has determined that the patient will wear a brace and be re-evaluated in four months time.

Manufacturer Narrative

An mdr is indicated for this complaint.Patient was implanted with a prodisc l device at the l5/s1 level on (b)(6) 2023.Following the implantation surgery, the patient was found to have bilateral pars fractures at the index level.The patient is not experiencing any symptoms.The surgeon has determined that the patient will wear a brace and be re-evaluated in four months time.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level defined in the risk documentation.A review of the risk documentation found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.There are no previous issues or capas associated with the complaint.The pdl device remains implanted within the patient, therefore no device evaluation could be completed.Bracing was needed for the bilateral pars fractures.A cause for the fractures is unknown, and no anomalies were identified during the course of the investigation.The submission is 2 of 3 devices involved in this event.

Event Description

Complaint is a follow-up to mdr 2024-00006.Patient was implanted with a prodisc l device at the l5/s1 level on (b)(6) 2023.Following the implantation surgery, the patient was found to have bilateral pars fractures at the index level.The patient is not experiencing any symptoms.The surgeon has determined that the patient will wear a brace and be re-evaluated in four months time.One month into bracing the decision was made to remove the pdl implant.Removal was completed on (b)(6) 2024.Patient was revised to alif with posterior fixation screws.

Manufacturer Narrative

An mdr is indicated for this complaint.Complaint is a follow-up to (b)(4).Patient was implanted with a prodisc l device at the l5/s1 level on (b)(6) 2023.Following the implantation surgery, the patient was found to have bilateral pars fractures at the index level.The patient is not experiencing any symptoms.The surgeon has determined that the patient will wear a brace and be re-evaluated in four months time.One month into bracing the decision was made to remove the pdl implant.Removal was completed on (b)(6) 2024.Patient was revised to alif with posterior fixation screws.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level defined in the risk documentation.A review of the risk documentation found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The prodisc l device was returned and will be evaluated under exponent's approved device evaluation protocol.The evaluation will be recorded under report number (b)(4).The removal was completed due to the bilateral pars fractures.A cause for the fractures is unknown, and no anomalies were identified during the course of the complaint investigation.The submission is 2 of 3 devices involved in this event.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE LARGE, 10MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 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
• MDR Report Key: 18537055
• MDR Text Key: 333159887
• Report Number: 3007494564-2024-00007
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193111708
• UDI-Public: 00843193111708
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDL-L-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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: 50 YR
• Patient Sex: Male