MAUDE Adverse Event Report: IZI MEDICAL PRODUCTS, LLC SNAP ON SPHERZ; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number PM8005

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

Snap-on spherz for stealth spine surgery.Product not functioning properly.When snapped onto instruments, breaks off during case.Product also slipping off of instruments.No harm: event reached patient, but no harm was evident.

• Brand Name: SNAP ON SPHERZ
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): IZI MEDICAL PRODUCTS, LLC; 5 easter court,; suite j; owings mills MD 21117
• MDR Report Key: 14986220
• MDR Text Key: 295690227
• Report Number: 14986220
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2022,07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM8005
• Device Lot Number: 20221274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Female
• Patient Race: White