MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L OUS SUPERIOR ENDPLATE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

The information provided by the reporter suggests that the patient's pain and need for surgical intervention were caused by the device.The information indicates the device was malpositioned off of midline based on communications and imaging from the reporter.The pain may have been permanent if it were not for surgical intervention.There were no indications of patient comorbidities or device malfunctions.This led to a determination that this was a reportable adverse event.Device part and lot numbers were not provided to complete a device history record review.Complaint history indicates this is the 1st complaint of this nature within the review period.The risks associated with the malposition of the device are identified and determine to be acceptable based on the prodisc l dfmea.No device was returned for evaluation.There was no explanation why the device could not be retrieved.Lbl430 rev.4 includes instructions to verify implant positioning in relation to the midline in both a lateral and ap view.These instructions are noted at multiple steps throughout the implantation process as well as a final check before completing the procedure.This submission is for 1 of 3 devices involved in the event.

Event Description

A patient underwent prodisc l revision on (b)(6) 2021.The prodisc l was implanted at l5/s1.The diagnosis/date of event was made on (b)(6) 2021.The removal was performed because the prodisc l device was not placed well (bad placement, malpositioned) which is causing or contributing to the patient's reported back pain.Imaging provided suggests the implant was off of the vertebral mid-line in a medial-lateral direction.The prodisc l was replaced with an unknown cage to convert the patient to a lumbar fusion.

Event Description

A patient underwent prodisc l revision on (b)(6) 2021.The prodisc l was implanted at l5/s1.The diagnosis/date of event was made on (b)(6) 2021.The removal was performed because the prodisc l device was not placed well (bad placement, malpositioned) which is causing or contributing to the patient's reported back pain.Imaging provided suggests the implant was off of the vertebral mid-line in a medial-lateral direction.The prodisc l was replaced with an unknown cage to convert the patient to a lumbar fusion.

Manufacturer Narrative

The information provided by the reporter suggests that the patient's pain and need for surgical intervention were caused by the device.The information indicates the device was malpositioned off of midline based on communications and imaging from the reporter.The pain may have been permanent if it were not for surgical intervention.There were no indications of patient comorbidities or device malfunctions.This led to a determination that this was a reportable adverse event.Device part and lot numbers were not provided to complete a device history record review.Complaint history indicates this is the 1st complaint of this nature within the review period.The risks associated with the malposition of the device are identified and determine to be acceptable based on the prodisc l dfmea.No device was returned for evaluation.There was no explanation why the device could not be retrieved.Lbl430 rev.4 includes instructions to verify implant positioning in relation to the midline in both a lateral and ap view.These instructions are noted at multiple steps throughout the implantation process as well as a final check before completing the procedure.Updated information: confirmation was received indicating the removal hospital had disposed of the explanted devices.The devices are not available for retrieval, and the hospital did not record the device part and lot numbers.The patient information, implanting surgeon, implanting hospital, and year of implantation were used in an attempt to track the implant part and lot numbers through centinel spine records.Our record review indicated we do not have any patients from the indicated implanting surgeon or hospital.The implanting hospital, (b)(6) hospital in (b)(6), was given a formal request for implant traceability based on the patient name, date of birth, implanting surgeon, and year of implantation.The hospital replied indicating they have no records of the indicated patient receiving treatment with prodisc l devices.The revising surgeon was contacted again to confirm the information initially provided was accurate.The revising surgeon confirmed the information initially provided for traceability was the correct information that was received by the surgeon at the time of removal.There are no other options to trace the implants used on this patient.Without the part and lot numbers, device history records cannot be identified for review.This submission is for 1 of 3 devices involved in the event.

• Brand Name: PRODISC L OUS SUPERIOR ENDPLATE
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 12455128
• MDR Text Key: 272860112
• Report Number: 3007494564-2021-00078
• Device Sequence Number: 1
• Product Code: MJO
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR