MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number 6972650

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Numbness (2415)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via manufacturing representative regarding patient with intermittent burning in neck, bilateral upper extremity numbness, ventral protrusion suggested for c4-7 anterior cervical disectomy and fusion.This event was revision surgery.Event occurred intra-op.It was reported that procedure was to remove a prestige lp implant from the level of c5-6.Device was implanted on (b)(6) 2019 and date of explant was (b)(6) 2021.No patient symptoms reported.Device is being returned.No further complications reported.Patients symptoms continued and were not fixed by the prestige implant.Patient also complained of a ¿glitch¿ with the prestige lp implant.

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11336687
• MDR Text Key: 232146640
• Report Number: 1030489-2021-00212
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00613994493675
• UDI-Public: 00613994493675
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6972650
• Device Catalogue Number: 6972650
• Device Lot Number: 0734020W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2021
• Date Device Manufactured: 06/19/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 73