MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. INVIZIA 1-LEVEL ACDF PLATE - 20MM; INVIZIA ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	07.01615.002
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3012447612-2019-00543.
Event or Problem Description
It was reported that a distributor received packages labeled as being plates with screws inside.There was no reported patient involvement, this was found prior to surgery.This is report one of two.
Additional Manufacturer Narrative
The device was returned.A screw was inside the packaging labeled for a plate and the complaint was confirmed.An ie and hhe was initiated for this event and determined that the error was caused by a printing error at the memphis facility.
Event or Problem Description
It was reported that a distributor received packages labeled as being plates with screws inside.There was no reported patient involvement, this was found prior to surgery.This is report one of two.

• Brand Name: INVIZIA 1-LEVEL ACDF PLATE - 20MM
• Common Device Name: INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9469845
• Report Number: 3012447612-2019-00542
• Device Sequence Number: 3078221
• Product Code: KWQ
• UDI-Device Identifier: 00889024325623
• UDI-Public: (01)00889024325623(10)AAA
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 07.01615.002
• Device Lot Number: AAA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1