MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C SK, MEDIUM, 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDSM5
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two pdc sk devices at c5-6 and c6-7 on (b)(6) 2025.Patient stated that when she awoke from implantation surgery, she was paralyzed with only the ability to move her eyes.Patient stated that the surgeon told her that the implant was pushed too far posterior, and that the implant had smashed her spine, and he had to take it out.A dhr review found no anomalies associated with the complaint.Complaint trending found that the probability of occurrence is remote.The risk assessment was reviewed and hazards and harms associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The sk devices remain implanted in the patient and were not returned; therefore, no evaluation could be completed.Additionally, imaging was not provided.There were no anomalies identified during the complaint investigation.The patient's postoperative complications were likely caused by surgical technique.The submission is 1 of 2 devices involved in this event.
Event or Problem Description
A patient was implanted with two pdc sk devices at c5-6 and c6-7 on (b)(6) 2025.Patient stated that when she awoke from implantation surgery, she was paralyzed with only the ability to move her eyes.Patient stated that the surgeon told her that the implant was pushed too far posterior, and that the implant had smashed her spine, and he had to take it out.Patient spent one week in the icu, followed by a month at a spine rehab center, patient continues to go to pt three times a week and has been unable to return to work.Patient had to relearn how to walk and continues to have arm and hand numbness.

• Brand Name: PRODISC C SK, MEDIUM, 5MM
• 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: 23538306
• Report Number: 3007494564-2025-00117
• Device Sequence Number: 10027309
• Product Code: MJO
• UDI-Device Identifier: 00843193113856
• UDI-Public: (01)00843193113856(17)300331(10)2025-0408
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: PDSM5
• Device Catalogue Number: N/A
• Device Lot Number: 2025-0408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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: 45 YR
• Patient Sex: Female