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

Model Number PDL-M-PT10S

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Neuropathy (1983); Dyskinesia (2363); Decreased Sensitivity (2683); Peripheral Nervous Injury (4414)

Event Date 02/15/2022

Event Type  Injury  

Event Description

A patient is 1 week post of complaining of sciatic pain as well as numbness and weakness in the big toe.The patient received prodisc l implants in l4/5 and l5/s1 on (b)(6) 2022.During the procedure, neural monitoring showed emg changes while trialing.10min after device implantation, the l5 nerve went down.Another 5 min later, it was fine again.In recovery the l5 nerve was exhibiting calf pain, big toe weakness, but no sciatic pain.Back pain was improved.The patient had weak dorsiflexion of the left ankle but left without an ankle foot orthosis.Patient is now developing sciatic pain in buttock and down to calf.Numbness and weakness in big toe.Consulting surgeon suggested radicular gram and ct scan with dye to try to understand why facets at l5 are asymmetrical and nerve release by posterior approach due the nerve not having enough space.Changes in neural monitoring suggests that there is a vascular element to the nerve.No pre-op complaints of leg pain from the patient, only back pain.

Manufacturer Narrative

It was reported that during a two level prodisc l case, 10min after device implantation, the l5 nerve went down.After another 5 minutes, the nerve was fine again.In recovery the l5 nerve was exhibiting calf pain, big toe weakness, but no sciatic pain.Back pain was improved.The patient had weak dorsiflexion of the left ankle but left without an ankle foot orthosis.Patient is now developing sciatic pain in buttock and down to calf.No indication of additional procedures or any additional information has been provided.Neural monitoring during the case suggests that the neurological deficit first appeared during trialing and implantation for periods of time.This information suggests that either the device or surgical approach to implant the device may have been a contributing factor.Dhr review found no anomalies associated with the complaint.Review of previous complaints trended neurological complications associated with pdl devices.The rate of these complaints was found to be within allowable limits based on the dfmea.The dfmea indicated there are two risks associated with "pain and/or patient injury (ie neurological deficit) and require reoperation".Each risk was determined to be "moderate" and acceptable noting the benefits of the device outweigh the risks.No device evaluation could be performed as the devices are still implanted in the patient.It was suggested that nerve release by posterior approach would possibly relieve symptoms due to the potential that the nerve does not having enough space.This suggests that surgical intervention may be required to alleviate the symptoms.It is unknown at present if surgical intervention occurred therefore 'other serious or important medical events' has been selected for the mdr submission.This submission is 6 of 6 for this event.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 10MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer (Section G): HAMMILL MANUFACTURING COMPANY; 360 tomahawk drive; maumee OH 43537
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 13894168
• MDR Text Key: 292066409
• Report Number: 3007494564-2022-00022
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDL-M-PT10S
• Device Lot Number: 2020-1609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male