VSP System Fibula Cutting Guide with Implant PlacementRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816847020770), received between Nov 7, 2019 and Dec 16, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Inaccurate Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K120956, K133907, K192192); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 30-45 MINUTE DELAY WAS CAUSED FROM BURRING THE FIBULA SEGMENTS TO FIT THE PLATE. THE SURGEON INDICATED HE SHIFTED THE GUIDE ON THE FIBULA. THE GUIDE REGISTERED WELL BUT LIKELY IN A DIFFERENT ROTATION. THE PATIENT WILL REQUIRE A REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823207 ↗
• InjurySep 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING THE PROCESS OF A MANDIBLE RECONSTRUCTIVE SURGERY, A FIBULA CUTTING GUIDE WAS UTILIZED WHICH RESULTED IN DENTAL IMPLANT HOLES THAT DID NOT PROPERLY ALIGN TO THE PLANNED SURGICAL POSITIONS. AS A RESULT, THE DENTAL IMPLANT HOLES WERE NOT USED AND A REVISION SURGERY WAS SCHEDULED TO CORRECT THE PLACEMENT OF THE DENTAL IMPLANT HOLES. A REVIEW OF THE GUIDE FOUND THAT ALL REQUIREMENTS WERE MET AND NO DEFECTS WERE FOUND IN THE DESIGN OR MANUFACTURING OF THE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790071 ↗
• InjuryFeb 1, 2022Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  DURING A VSP RECONSTRUCTION PROCEDURE, IT WAS IDENTIFIED THAT THE FIBULA GUIDE WAS LABELED INCORRECTLY. THE GUIDE WAS LABELLED LEFT FIBULA TO RIGHT NECK; AND THE CORRECT SURGICAL PROCEDURE WAS LEFT FIBULA TO LEFT NECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417656 ↗
• InjuryNov 21, 2021Labelling, Instructions for Use or Training Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Inaccurate Information

  FOR A VSP RECONSTRUCTION PROCEDURE, THE SURGEON IDENTIFIED AN ERROR DOCUMENTED IN THE 3D SYSTEMS CASE REPORT. THE PLAN B VSP RECONSTRUCTION SURGICAL PLAN DOCUMENTED THE PLAN A FIBULA GUIDE IN ONE OF THE IMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849857 ↗
• InjuryJul 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DENTAL IMPLANT PLACEMENT ON THE FIBULA CUTTING GUIDE WITH IMPLANT PLACEMENT WAS PLACED ON THE ANTERIOR SURFACE INSTEAD OF THE POSTERIOR SURFACE. THE ISSUE WAS IDENTIFIED PRIOR TO SURGERY AND THE IMPLANT PLACEMENT FEATURE ON THE GUIDE WAS NOT USED. THE ISSUE CAUSED NO HARM TO THE PATIENT AND DID NOT CAUSE A DELAY IN SURGERY.

  Patient problems: No Code Available

  MAUDE report 10292304 ↗
• InjuryNov 7, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DENTAL IMPLANT PLACEMENT ON THE FIBULA CUTTING GUIDE WITH IMPLANT PLACEMENT WAS PLACED ON THE ANTERIOR SURFACE INSTEAD OF THE POSTERIOR SURFACE.

  Patient problems: No Code Available

  MAUDE report 9293209 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120956, K133907, K192192. One submission often covers many models, so check the product and lot details in each record.

• Z-1510-2022 · May 17, 2022 · Open, Classified
  3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile