MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L US PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 10MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number PDL-M-PT10S

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Vertebral Fracture (4520)

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

A patient received a prodisc l implant on (b)(6) 2020.On (b)(6) 2021, the device was explanted and replaced with an alif using unknown devices.The patient suffered a pars fracture and pain.The surgeon believes there is an unknown traumatic event which led to the fracture and pain.The patient reported pain after undergoing spinal traction.The prodisc l pe inlay was also dislodged from the inferior endplate.The superior endplate migrated anteriorly and subluxated over the pe inlay.The surgeon indicated the pain and fracture were not caused by the prodisc l device; however, previous complaints indicate these malfunctions have a more than remote chance of causing surgical intervention to preclude serious injury.The information and investigation suggest that the malfunction is likely due to the patient's traumatic event as indicated by the surgeon.There was no indication of a problem during manufacturing based on the device dhr review.The risk assessment for the device indicated the associated risks are identified, mitigated, and accepted.The device was retrieved and sent for scientific testing and analysis.If the results of the evaluation change the results of this investigation, a follow up submission will be completed.This submission is for 1 of the 3 devices involved in this event.

Event Description

A prodisc l removal procedure has been performed on monday (b)(6) 2021.The pdl implant is being removed due to pe inlay migration and superior endplate migration.A lateral x-ray image was provided showing the malfunction.Date of event/diagnosis was (b)(6) 2021.The patient has pain which started about 3 weeks ago after having spinal traction done at her chiropractor.The patient did not have any comorbidities.The surgeon believes that an unknown traumatic injury was the cause of the pdl inlay migration.Mri revealed bilateral fractures of the l5 pedicles.The surgeon does not believe the device caused or contributed to the patient's condition or symptoms.The surgeon replaced the pdl with a bone alif and posterior fixation.The case was completed without any incident or difficulty.

• Brand Name: PRODISC L US PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 10MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878810
• MDR Report Key: 11938263
• MDR Text Key: 254272012
• Report Number: 3007494564-2021-00047
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193111760
• UDI-Public: 00843193111760
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: PDL-M-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: H522623
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2018
• 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: 44 YR