MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. INVIZIA 2-LEVEL ACDF PLATE - 42MM; INVIZIA ANTERIOR CERVICAL PLATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference reports 3012447612-2021-00020 thru 3012447612-2021-00027.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.
Event or Problem Description
It was reported that a screw fractured and backed out post-op, which caused the construct to be unstable and fusion was not achieved.Additionally, the cage was found to be cracked.A 2-level plate, 6 screws, and cage were removed during a revision surgery.This is report seven of eight for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for one (1) of one (1) returned 42mm invizia 2 lvl plate (pn 07.01616.005) for the failure of plate did not provide stability post operation.Medical records were provided in form of x-rays.The provided x-rays confirms that an implant was migrated.Potential cause despite the products were returned for evaluation, root cause can't be established.Patient conditions and events prior to the surgery are not known.Insufficient information was provided.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that a screw fractured and backed out post-op, which caused the construct to be unstable and fusion was not achieved.Additionally, the cage was found to be cracked.A 2-level plate, 6 screws, and cage were removed during a revision surgery.This is report seven of eight for this event.

• Brand Name: INVIZIA 2-LEVEL ACDF PLATE - 42MM
• Common Device Name: INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11302499
• Report Number: 3012447612-2021-00026
• Device Sequence Number: 19021039
• Product Code: KWQ
• UDI-Device Identifier: 00889024325746
• UDI-Public: (01)00889024325746(10)62440699
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: N/A
• Device Catalogue Number: 07.01616.005
• Device Lot Number: 62440699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention