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

Model Number	6972650
Health Effect - Clinical Codes	Burning Sensation (2146); Numbness (2415)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 11336687
• Report Number: 1030489-2021-00212
• Device Sequence Number: 883425
• Product Code: MJO
• UDI-Device Identifier: 00613994493675
• UDI-Public: 00613994493675
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6972650
• Device Catalogue Number: 6972650
• Device Lot Number: 0734020W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 73