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

Model Number PDL-M-IP00S

Device Problems Mechanical Problem (1384); Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem Loss of Range of Motion (2032)

Event Date 07/27/2021

Event Type  malfunction  

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 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
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): HAMMILL MANUFACTURING COMPANY; 360 tomahawk drive; maumee OH 43537
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878810
• MDR Report Key: 12337982
• MDR Text Key: 267117801
• Report Number: 3007494564-2021-00073
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193111753
• UDI-Public: 00843193111753
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PDL-M-IP00S
• Device Lot Number: 2020-1441
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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 Age: 50 YR