MAUDE Adverse Event Report: CENTINEL SPINE PRODISC L SUPERIOR END PLATE LARGE 3-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-L-SP03S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Multiple Fractures (4519)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Additional 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 1 of 3 devices involved in this event.
Event or Problem 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.
Additional 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 07dec2023.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 pdl-rd-0012.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 1 of 3 devices involved in this event.
Event or Problem 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.

• Brand Name: PRODISC L SUPERIOR END PLATE LARGE 3-STERILE
• Common Device Name: 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: 18536532
• Report Number: 3007494564-2024-00006
• Device Sequence Number: 6751189
• Product Code: MJO
• UDI-Device Identifier: 00843193114952
• UDI-Public: 00843193114952
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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 Model Number: PDL-L-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male