MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW, 6.5MM X 35MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 701M6535

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 four of 14 for this event.

Manufacturer Narrative

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 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 four of 14 for this event.

Manufacturer Narrative

Corrected information in b5.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 four of 14 for this event.

• Brand Name: POLYAXIAL SCREW, 6.5MM X 35MM
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10713155
• MDR Text Key: 212347093
• Report Number: 3012447612-2020-00632
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K171907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,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: Health Professional
• Device Catalogue Number: 701M6535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other