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

Model Number	PDL-M-SP03S
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Limb Pain (4836)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is an indication of an mdr report being required for this complaint.It was reported that a patient was implanted with a prodisc l at level l4-5 on (b)(6) 2024.The patient had difficult anatomy and the implant was undersized, additionally a tdr at level l5-s1 was skipped due to the anatomy.Approximately a month and a half after implantation the patient experienced a traumatic fall and this caused the inferior endplate to subside into the inferior vertebral body.Patient is having new leg pain since the fall occurred.Surgeon plans to revise the patient and add posterior fusion at l4-5 and l5-s1.The date of revision was not provided.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 hazards associated with the complaint are identified and mitigated to a level where the clinical benefits of the surgery outweigh the risks.A device evaluation could not be completed as the pdl device remains implanted within the patient.The revision is to be completed due to implant subsidence.The implant subsidence was caused by patient trauma.The submission is 1 of 3 devices involved in this event.
Event or Problem Description
Patient was implanted with a prodisc l at level l4-5 on (b)(6) 2024.The patient had difficult anatomy and the implant was undersized, additionally a tdr at level l5-s1 was skipped due to the anatomy.Approximately a month and a half after implantation the patient experienced a traumatic fall and this caused the inferior endplate to subside into the inferior vertebral body.Patient is having new leg pain since the fall occurred.Surgeon plans to revise the patient and add posterior fusion at l4-5 and l5-s1.The date of revision was not provided.

• Brand Name: PRODISC L SUPERIOR END PLATE MEDIUM 3-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: 19404453
• Report Number: 3007494564-2024-00037
• Device Sequence Number: 12501639
• Product Code: MJO
• UDI-Device Identifier: 00843193114983
• UDI-Public: 00843193114983
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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-M-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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: Male