MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLOSURE TOP VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02010.001

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. 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. Reference report numbers 3012447612-2020-00629 thru 3012447612-2020-00642.

Event Description

It was reported that the patient is having a possible allergic reaction to some spinal implants. The installed implants include an epic construct and a breckenridge cage. The patient is allergic to nickel and may be sensitive to cobalt chrome. Allergy tests are on-going and a plan for care has not yet been made. This is report 13 of 14 for this event.

Manufacturer Narrative

Corrected information in b5. Information added to d8 and h6: component, investigation type, findings, and conclusions. This follow-up report is being submitted to relay additional information. Summary: the complaint is unrefuted for the vitality construct causing an allergic reaction. Medical records were not provided for review. Device evaluation: product was not returned as it remains implanted. A device evaluation could not be performed. Potential cause: root cause was unable to be determined with the available information. Dhr review and related actions the lot numbers were not provided, so the dhr review could not be performed. Device use: these devices are used for treatment. A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that the patient is having a possible allergic reaction to some spinal implants. The installed implants include a pedicle screw construct. The patient is allergic to nickel and may be sensitive to cobalt chrome. Allergy tests are on-going and a plan for care has not yet been made. This is report 13 of 14 for this event.

• Brand Name: CLOSURE TOP
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10713312
• Report Number: 3012447612-2020-00641
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 07.02010.001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Other