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

Model Number PDL-M-IP08S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 01/12/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was implanted on (b)(6) 2022 with a prodisc l device at l5/s1 level.Following surgery the patient began to experience pain and x-rays revealed that the implant had shifted.The surgeon indicated that there was no problem or malfunction of the device itself.The patient was the revised to a fusion device on (b)(6) 2023.A review of the device history files found no anomalies associated with the complaint.Complaint trending found that the rate of complaints was within the levels established within the risk documentation.The review of the risk assessment found that the harms and hazardous situations associated with the complaint are identified and mitigated to a level where the benefits outweigh the risks.The device was returned and an evaluation and report will be completed by exponent.The pdl removal was completed due to device migration that was causing the patient pain.No cause for the migration was identified and it was stated that there was no problem or malfunction of the device.The cause of the migration is unknown.This report is for 1 of 3 devices involved in this event.

Event Description

It was reported that a patient was implanted on (b)(6) 2022 with a prodisc l device at l5/s1 level.Following surgery the patient began to experience pain and x-rays revealed that the implant had migrated.The surgeon indicated that there was no problem or malfunction of the device itself.The patient was the revised to a fusion device on (b)(6) 2023.

• Brand Name: PRODISC L INFERIOR END PLATE, MEDIUM 8-STERILE
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): HAMMILL MANUFACTURING COMPANY; 360 tomahawk drive; maumee OH 43537
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 16283335
• MDR Text Key: 308627218
• Report Number: 3007494564-2023-00002
• Device Sequence Number: 1
• Product Code: MJO
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDL-M-IP08S
• Device Lot Number: 2022-0670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2022
• 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: 46 YR
• Patient Sex: Male