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

Model Number PDL-M-SP11S

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Pain (1994)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

The information provided by the reporter indicates the patient came to post-op follow up complaining of back pain.Imaging taken by the surgeon found the pe inlay had dislodged and the superior endplate had migrated anteriorly.There was no indication by the patient or surgeon to indicate how this migration and expulsion had occurred.There was no indication of any patient comorbidities.A removal procedure was scheduled for (b)(6) 2021.No confirmation was provided indicating the procedure went ahead as scheduled.Based on the reported malfunction and surgical intervention an mdr submission is required.Dhr review did not find any issues in manufacturing which may have caused or contributed to this complaint.Review of complaint history found the rate of complaints to be within allowable limits based on the dfmea for prodisc l us.The risk assessment determined inlay expulsion and migration are identified hazards with varying possible harms.The risks associated with this complaint are identified and mitigated.This report is for the prodisc l superior endplate, 1 of 3 submissions total for this event.

Event Description

Patient received a prodisc l medium 10mm implant at l5-s1 on (b)(6) 2020.The patient came for the first time to follow up with the surgeon.The patient had back pain starting 1 week prior to the follow up exam with the surgeon.The patient indicated nothing happened when the pain started.The surgeon has not provided a possible reason for the migration or inlay expulsion.There has been no indication the patient has any contributing comorbidities.A removal procedure was scheduled for (b)(6) 2021.

Manufacturer Narrative

A removal procedure was scheduled for (b)(6) 2021.After the initial report for this mdr, the complaint reporter confirmed the case went ahead as scheduled.The patient was revised using an unknown plate and cage to fuse the level.The explanted prodisc l devices were not retrieved for evaluation.The complaint reporter indicated they were lost by the hospital.This follow-up report is for the prodisc l superior endplate, 1 of 3 submissions total for this event.

Event Description

After the initial mdr report, information was provided which confirmed the removal procedure went ahead as scheduled.The patient was converted to a fusion using an unknown plate and cage.

• 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
• MDR Report Key: 11474566
• MDR Text Key: 239510867
• Report Number: 3007494564-2021-00016
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193111807
• UDI-Public: 00843193111807
• Combination Product (y/n): N
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: PDL-M-SP11S
• Device Catalogue Number: N/A
• Device Lot Number: H382303
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR