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
Medical Device Problem Codes	Expulsion (2933); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided from the reporter links this patient to a previous complaint where the surgeon had difficulty seating the pe inlay into the inferior endplate.The patient has since suffered a pe inlay expulsion and superior endplate subluxation/migration from l5 - s1.The inferior endplate remains in position.There was no indication of trauma.The patient was not suffering any symptoms as a result of the malfunction.The malfunction was identified at 6 month follow up via x-rays on an unknown date.The patient under went revision and removal of the prodisc l devices.They were replaced with unknown artificial discs which do not use a keel for fixation.The revision was completed without any issues.This information led to a determination that an mdr would be required.No other submissions are required.Dhr review did not find any issues in manufacturing which may have contributed.Complaint history linked this complaint to a previous complaint.The linked previous complaint was attributed to damaged instrumentation and the surgeon's technique.The implantation case did result in the implant being implanted as expected without patient harm despite the intraoperative struggles.Additionally the rate of complaints was found to be acceptable based on the device risk assessment.The devices were retrieved and sent to a third party laboratory for analysis.If information is received that changes the results of this complaint, a follow up submission will be sent.Review of the previous complaint and the x-rays provided from this complaint suggest that the implant positioning may have been a contributing factor.The surgeon does not perform a typical amount of posterior release at the treated level.The implantation x-rays show the superior endplate is not centered anterior-posterior in the l5 vertebral body.There is more bone posterior to the keel than anterior.The endplates are seen in a "fish mouth" condition meaning they are not parallel.The endplates being out of parallel may have contributed to the inlay expulsion from the endplate.The positioning of the superior endplate may have contributed to the endplate migration.These two conditions are likely why the pre-removal x-ray shows the superior endplate and pe inlay positioned together.It is likely that both migrated to their position at the same time.The information and investigation suggest the implant positioning is the likely cause for this complaint.The positioning may be attributed to the surgical technique used during implantation.The cause of the event may be a use error in the implantation of the device.This report is for 1 of 3 devices involved in this event.
Event or Problem Description
A patient received a prodisc l implant at l5-s1 on (b)(6) 2021.During implantation, the surgeon had difficulty seating the pe inlay into the inferior endplate.This challenge was overcome and the patient's implantation was completed without patient harm.On an unknown date at a 6 month follow up exam, the patient's x-rays revealed the pe inlay had expelled from the inferior endplate and the superior endplate migrated anteriorly out of the disc space.The patient was not experiencing any complications or symptoms.The patient was scheduled for removal.On (b)(6) 2021, the patient underwent removal of the prodisc l devices.The devices were replaced with another artificial disc from an unknown manufacturer.The device was selected based on design without a keel.Revision was completed without issue.Patient status post-op is unknown.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE LARGE, 10MM
• Common Device Name: 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: 12824036
• Report Number: 3007494564-2021-00104
• Device Sequence Number: 16484397
• Product Code: MJO
• UDI-Device Identifier: 00843193111708
• UDI-Public: 00843193111708
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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 Expiration Date: 05/31/2021
• Device Model Number: PDL-L-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: H572461
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2018
• 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: 22 YR
• Patient Sex: Female