MAUDE Adverse Event Report: BIOPSYBELL S.R.L. EASYNJECT KVT GUN; CEMENT MIXER

Model Number	KVT GUN
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ifu for the cement used states that "the surgeon is responsible for any complications or harmful consequences which might result from an erroneous indication or operative technique, improper use of the equipment and failure to comply with the safety instructions given in the directions for use.".
Event or Problem Description
The patient did have canal compression and had to be monitored.No other person in the room was affected.Patient did not have mortality only complication due to cement being injected into spinal column.The cement was injected after waiting five minutes post mixing with injection between eight and 10 minutes, cement leaked on level 3 after waiting over 5-8 minutes post mixing.The trocars were beyond the posterior third and in bipedicular setup.Surgeon believes the kvtgun had to much pressure.

• Brand Name: EASYNJECT KVT GUN
• Common Device Name: CEMENT MIXER
• Manufacturer (Section D): BIOPSYBELL S.R.L.; via a.manuzio n.24; mirandola modena, 41037 ; IT 41037
• Manufacturer (Section G): BIOPSYBELL S.R.L.; via a. manuzio n.24; mirandola, modena 41037 ; IT 41037
• Manufacturer Contact: elke carter ; 3670 flowood drive; flowood, MS 39232 ; 6019191119
• MDR Report Key: 25061765
• Report Number: 3008583793-2026-00001
• Device Sequence Number: 18652919
• Product Code: JDZ
• UDI-Device Identifier: 08033860036591
• UDI-Public: 08033860036591
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: KVT GUN
• Device Catalogue Number: KVTGUN-DS1
• Device Lot Number: 25072145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown