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

Model Number PDL-L-PT10S

Device Problems Fracture (1260); Expulsion (2933); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

The reporter, follow up conference call, and imaging provided confirmed a complaint that a pdl construct has superior endplate subluxation, pe inlay expulsion, and pe inlay fracture.The patient has been completely asymptomatic despite the malfunction.The current plan is to revise the patient in (b)(6) of 2021.Peer to peer discussion suggests the sup.Endplate angle as well as the keel ap position may be contributing factors in how this malfunction occurred.Patient activities may have been a factor as well, but the patient has no indicated a specific event that may have resulted in the pe inlay expulsion.Revision to angled superior and inferior endplates or alif is likely to occur.Dhr review was completed with no noted issues during manufacturing.The rate of complaints was found to be within allowable limits based on the pocs identified in the risk assessment.Risks were identified in relation to this complaint.There were no indications of any new risks or increases in the pocs.Device evaluation could not be performed as the device remains implanted in the patient as this time.The information provided and the investigation suggest multiple contributing factors to this malfunction.The patient's activities (body building), the superior endplate position, and the superior endplate angle selection were all noted as factors which may have contributed to this malfunction.This submission is for the 3rd of 3 devices involved in the event.

Event Description

Patient received a pdl construct at l5-s1 on (b)(6) 2019.Follow up imaging on 5/18/20 show no signs of abnormalities.Images on (b)(6) 2020 found superior endplate subluxation, pe inlay expulsion, and pe inlay fracture with a fragment migrated anterior to s1.Patient has been completely asymptomatic.No medical intervention has been performed as the patient is asymptomatic.Based on a 3/10/2021 conference call with the treating surgeon, the patient will likely be revised in (b)(6) 2021.The patient may be revised with a new pdl construct using angled sup.And inf.Endplates.Alif may be used based on patient activities.This will be determined closer to revision surgery date.No specific date has been scheduled.

Manufacturer Narrative

Updated information: the patient underwent revision and removal of the prodisc l devices on (b)(6) 2021.There was no indication of any patient symptoms or complications beyond the reported malfunction.The prodisc l devices were replaced with new prodisc l devices using different angles on the superior and inferior endplates to improve biomechanics.The explanted device was retrieved and sent for third party testing and analysis.The devices are pending analysis.If information is provided that changes the outcome of the complaint investigation or the information in this submission an additional follow up will be submitted.The updated information has not changed the conclusions of the initial investigation into the reported malfunction.This is follow up 1 for 1 of 3 devices involved in this event.

Event Description

A patient who previously suffered a prodisc l superior endplate subluxation, pe inlay expulsion, and pe inlay fracture has undergone surgical intervention.The surgical intervention was performed on (b)(6) 2021.The prodisc l construct was removed and replaced with a new prodisc l construct using a pdl-l-sp03 large 3 deg superior endplate, pdl-l-pt10s large 10mm pe inlay, and pdl-l-ip08s large 8 deg inferior endplate.There was still no indication of any patient symptoms or complications beyond the malfunction.The patient was considered asymptomatic.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE LARGE, 10MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 11556509
• MDR Text Key: 243555058
• Report Number: 3007494564-2021-00021
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193111708
• UDI-Public: 00843193111708
• Combination Product (y/n): N
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: PDL-L-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: H572460
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR