MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L INFERIOR END PLATE MEDIUM 8-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-IP08S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implant with a pdl device at l5-s1 on (b)(6) 2025.Following surgery, the patient had developed leg pain that was not present prior to surgery.Imaging showed that the implant was too far posterior.The surgeon revised the implant on (b)(6) 2025 by removing the inlay, repositioning the endplates and inserting a new inlay.The dhr reviews found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level outlined in the risk documentation.A review of the risk documentation found that the hazards associated with this complaint are identified and mitigated to a level where the clinical benefits outweigh the harms.The prodisc l implant was not returned as the plates were repositioned in the patient and the poly inlay was discarded, therefore no device evaluation could be completed.Imaging was provided that showed the implant was too far from posterior.The prodisc l revision surgery was completed because the patient had new leg pain following surgery which was cause by the implant being placed too far posterior.The submission is 3 of 3 devices involved in this event.
Event or Problem Description
A patient was implant with a pdl device at l5-s1 on (b)(6) 2025.Following surgery, the patient had developed leg pain that was not present prior to surgery.Imaging showed that the implant was too far from posterior.The surgeon revised the implant on (b)(6) 2025 by removing the inlay, repositioning the endplates and inserting a new inlay.

• Brand Name: PRODISC L INFERIOR END PLATE MEDIUM 8-STERILE
• Common Device Name: 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: 22193244
• Report Number: 3007494564-2025-00053
• Device Sequence Number: 21159854
• Product Code: MJO
• UDI-Device Identifier: 00843193114976
• UDI-Public: (01)00843193114976(17)300331(10)2024-0977
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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-M-IP08S
• Device Catalogue Number: N/A
• Device Lot Number: 2024-0977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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: 64 YR
• Patient Sex: Male