MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L SUPERIOR PLATE, SIZE MEDIUM, 11, STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number PDL-M-SP11S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

Information provided by the reporter as well as copies of the imaging taken indicate the prodisc l pe inlay has dislodged/expelled from the inferior endplate.This may be contributing to the patient's continued pain.During the latest follow up where the patient was complaining of pain, the dislodged inlay was discovered.At the time of this complaint, there is no clear indication from the surgeon whether he will revise the patient.There is no indication from the surgeon what may have caused the inlay to dislodge from the inferior endplate.The surgeon felt there were no technical issues contributing to the inlay expulsion.This reported malfunction is likely to lead to surgical intervention to preclude serious injury thus an mdr submission is required.Dhr review did not find any problems during manufacturing which may have caused or contributed to the reported complaint.The rate of complaints was found to be within allowable limits based on the risk assessment.The risk assessment identified the risks associated with pe inlay dislodged/expelled, and there was no indication of any new risks based on the investigation.No device has been explanted for evaluation as of this complaint.During review of provided patient imaging, it was noted that the superior endplate does not appear to be centered anterior-posterior in the l5 vertebral body.Through the pre, post-op, and follow up images there is a shortened posterior height due to bone formation.This formation does not appear to be removed through the imaging, and is noticeable posterior to the pdl device.This may indicate the remobilization of the segment is not adequate.Decompression may not be adequate for this patient.This submission is the 1st of 3 devices involved in this event.

Event Description

A patient received a prodisc l construct on (b)(6) 2018.During a patient follow up appointment on an unknown date, the patient complained of pain.Imaging was taken on an unknown date at or after the follow up exam.The imaging revealed the prodisc l pe inlay had dislodged from the inferior endplate.The pe inlay expulsion is likely to lead to surgical intervention to preclude serious injury.

• Brand Name: PRODISC L SUPERIOR PLATE, SIZE MEDIUM, 11, 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): 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: 11585655
• MDR Text Key: 244390598
• Report Number: 3007494564-2021-00022
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193111807
• UDI-Public: 00843193111807
• 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
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: PDL-M-SP11S
• Device Catalogue Number: N/A
• Device Lot Number: H378046
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2017
• 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: 29 YR