MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. PRE-CONTOURED OCCIPITAL ROD, TI (100 DEG.); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number	07.01712.001
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inventory, a hospital discovered two virage rods that do not match the label on the packaging.There was no patient involvement.This is report two of two for this event.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Additional Manufacturer Narrative
Inspection: the returned device was examined.Visual inspection revealed the angle of the rods appear to be larger than 100 degrees.A dimensional inspection was performed and found the rod to measure 115 degrees.Per the drawing, the angle should measure 100 degrees +/- 1 degree.Dhr review: the dhr was reviewed.The dhr stated there were no manufacturing issues and the device was likely conforming.It was later found that operator error contributed to incorrect dimensions on parts in this lot.Potential root cause: the root cause can be attributed to operator error in manufacturing and inspection.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.Reference report 3012447612-2023-00250.
Event or Problem Description
It was reported that during inventory, a hospital discovered two virage rods that do not match the label on the packaging.There was no patient involvement.This is report two of two for this event.

• Brand Name: PRE-CONTOURED OCCIPITAL ROD, TI (100 DEG.)
• Common Device Name: VIRAGE OCT SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; wesminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17683324
• Report Number: 3012447612-2023-00251
• Device Sequence Number: 14105579
• Product Code: KWP
• UDI-Device Identifier: 00889024328631
• UDI-Public: (01)00889024328631(10)CT153157
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133556
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: Health Professional
• Device Catalogue Number: 07.01712.001
• Device Lot Number: CT153157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic