MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ZEVO ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	G7724015
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source foreign : (b)(6).Delay in procedure, more than 60 minutes.Intervention required: revision surgery.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from hcp via manufacturing representative.Pre-op diagnosis: cross-link was confirmed in the judgment of solid fusion, it was decided to remove the implant.Patient achieved solid fusion.Levels implanted: c4-7.It was reported that the event occurred because the person in charge of the facility(b)(4) did not check the operation history that implant remained.The removal equipment was shipped from (b)(4) loaner, and sterilized at high speed and removal was performed.Surgery was delayed more than 60 min.Update (b)(6) 2020 -->the cause of the event was that the sales rep did not confirm the initial operation date with the physician.The patient's name was informed to the distributor by the physician.Based on the name, the anterior cervical plate system "venture" corresponded to the history of the distributor, and the distributor contacted the sales rep.Therefore, a "venture" was prepared as a removal device, but the implant that was actually in the patient¿s body was "zevo", and it could not be removed so it had to bring in the "zevo" device again and remove it.Update (b)(6) 2020; this was the revision surgery which was performed on (b)(6) 2020.After bone union was checked to be achieved, as it was requested by the patient, removal was performed.

• Brand Name: ZEVO ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10435732
• Report Number: 3004209178-2020-14478
• Device Sequence Number: 11510997
• Product Code: KWQ
• UDI-Device Identifier: 00643169327870
• UDI-Public: 00643169327870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2024
• Device Model Number: G7724015
• Device Catalogue Number: G7724015
• Device Lot Number: H5328088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/21/2020
• 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: Other; Required Intervention