MAUDE Adverse Event Report: CENTINEL SPINE, LLC. INFERIOR END PLATE MEDIUM 0-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-IP00S
Medical Device Problem Codes	Mechanical Problem (1384); Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon inserted the pe inlay into the endplates without following the indicated surgical technique form prodisc l.The distractor was not used to progress the inlay into place and open the disc space.The inlay was pushed and mallet into place using only the inlay pusher.The surgeon thought the inlay was seated, but once the inserter was removed he realized the inlay was not properly seated.The surgeon could not re-attach the inserter to fully seat the inlay.It was at this point the surgeon decided that the best course of action was to remove the pe inlay and close the patient with the endplate intact.The patient appeared to have restored disc height and the endplates were positioned well enough for the surgeon to feel confident the surgery was a success from a neurological standpoint.The surgeon indicated directly that there was no problem with the implants or instruments used during the procedure, and this event was solely due the surgical technique used.There has been no indication of a scheduled revision procedure and the patient has been doing fine.Dhr review did not find any problems during manufacturing which may have contributed to the complaint.Complaint history determined the rate of complaints is within allowable limits indicated in the risk assessment.The risk assessment identified multiple risks related to this complaint.No devices were returned for evaluation.The endplates remain implanted in the patient.The information provided by the reporter indicates this complaint was caused by the surgeon's surgical technique.The pe inlay was inserted without the use of the distractor as indicated in the prodisc l surgical technique guide.This submission is for 1 of 3 devices involved in this event.
Event or Problem Description
A patient was scheduled and diagnosed for prodisc l implantation at l5-s1.The patient underwent implantation surgery on (b)(6) 2021.During the procedure, the access surgeon provided a limited window to the vertebral level.The spine surgeon prepared the disc space and inserted the prodisc l endplates into the disc space.The surgeon then proceeded to place the pe inlay into the endplates without following the indicated surgical technique form prodisc l.The distractor was not used to progress the inlay into place and open the disc space.The inlay was pushed and mallet into place using only the inlay pusher.The surgeon thought the inlay was seated, but once the inserter was removed he realized the inlay was not properly seated.The surgeon could not re-attach the inserter to fully seat the inlay.It was at this point the surgeon decided that the best course of action was to remove the pe inlay and close the patient with the endplate intact.The patient appeared to have restored disc height and the endplates were positioned well enough for the surgeon to feel confident the surgery was a success from a neurological standpoint.The surgeon indicated directly that there was no problem with the implants or instruments used during the procedure, and this event was solely due the surgical technique used.The surgeon has not scheduled any additional intervention.The patient woke from surgery happy with positive results.The patient was sent home the same day of the procedure.The surgeon is closely monitoring this patient.As of (b)(6) 2021, the patient is doing fine.

• Brand Name: INFERIOR END PLATE MEDIUM 0-STERILE
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 12337982
• Report Number: 3007494564-2021-00073
• Device Sequence Number: 17415093
• Product Code: MJO
• UDI-Device Identifier: 00843193111753
• UDI-Public: 00843193111753
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: PDL-M-IP00S
• Device Lot Number: 2020-1441
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR