VSP System Fibula Cutting GuideRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816847020794), received between Nov 14, 2016 and Apr 21, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  DURING A MAXILLOFACIAL RECONSTRUCTIVE SURGERY, IT WAS REPORTED THAT THE POSTERIOR CUT ON THE FIBULA RESULTED IN A FIBULA SEGMENT APPROXIMATELY 2MM LONGER THAN WAS REQUIRED. THIS CAUSED A MISALIGNMENT BETWEEN THE PREDICTIVE HOLES AND THE CUSTOM RECONSTRUCTION PLATE. TO RECTIFY THE ISSUE, THE FIBULA WAS ADJUSTED BY REMOVING SMALL PIECES OF THE FIBULA SEGMENT, RESULTING IN A SUCCESSFUL RECONSTRUCTION OF THE MANDIBLE. SUBSEQUENTLY, THE PREDICTIVE HOLES WERE RE-DRILLED IN THE FIBULA SEGMENT TO ACCOUNT FOR THE REMOVAL OF BONE. THIS LED TO AN ESTIMATED DELAY OF 25 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788150 ↗
• InjuryMar 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  DURING A MAXILLOFACIAL RECONSTRUCTIVE SURGERY, IT WAS REPORTED THAT THE PREDICTIVE DRILL HOLES DID NOT LINE UP WITH THE CUSTOM RECONSTRUCTION PLATE. THE SURGEON DRILLED ADDITIONAL HOLES IN ORDER TO FIT THE PLATE TO THE PATIENT'S ANATOMY. THE SURGERY WAS SUCCESSFUL WITH NO OBSERVABLE CLINICAL SYMPTOMS REPORTED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16614626 ↗
• InjuryNov 18, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING A RECONSTRUCTION SURGERY FEATURING VIRTUAL SURGICAL PLANNING, THE USE OF A FIBULA CUTTING GUIDE LED TO A FIBULA SEGMENT WHICH WAS REPORTED TO BE TOO LARGE FOR THE MANDIBLE BY APPROXIMATELY 5 MM. THE SURGEON MANUALLY CUT THE SEGMENT AGAIN TO ACHIEVE PROPER FIT AND REPORTED A 60-MINUTE DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827763 ↗
• InjuryNov 7, 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 THE FOLLOWING ISSUES: THE VSP RECONSTRUCTION SURGICAL PLAN DOCUMENTED ON THE 3D SYSTEMS CASE REPORT PROVIDED TO THE SURGEON DID NOT ALIGN WITH THE VIRTUAL SIMULATED PLAN. THE SURGICAL PROCEDURE WAS DOCUMENTED AS LEFT FIBULA TO RIGHT NECK; INSTEAD OF RIGHT FIBULA TO RIGHT NECK. THIS ISSUE WAS IDENTIFIED BY THE SURGEON PRIOR TO SURGERY. 3D SYSTEMS VERIFIED THAT THE MANUFACTURED ANATOMICAL FIBULA CUTTING GUIDE WAS DESIGNED TO THE CORRECT RIGHT FIBULA RIGHT NECK SURGICAL PLAN; AND THE ISSUE WAS ISOLATED TO A CASE REPORT DOCUMENTATION ERROR. 3D SYSTEMS CORRECTED THE CASE REPORT AND SUBMITTED A NEW REVISION TO THE SURGEON PRIOR TO SURGERY. THE SURGICAL OUTCOME WAS SUCCESSFUL WITH NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763649 ↗
• InjuryNov 14, 2016Device Markings/Labelling Problem; Device Markings/Labelling Problem

  SUMMARY: A SALES REPRESENTATIVE CONTACTED 3D SYSTEMS ON (B)(6) 2015 AFTER OPERATING SURGEON REPORTED THAT THE FIBULA RECONSTRUCTION SEEMED "SHORT" IN THE MANDIBLE. THE SALES REP. EXPLAINED THAT THE SURGEON SEEMED TO THINK THE WIDTH OF THE FIBULA RECONSTRUCTION SHOULD BE THE HEIGHT AND THE HEIGHT SHOULD BE THE WIDTH. THIS ESSENTIALLY MEANT THAT THE LATERAL SURFACE OF THE FIBULA WAS NOT FACING BUCCAL, BUT IN FACT WAS FACING SUPERIOR PROCEDURE AT TIME OF INCIDENT: MANDIBLE RECONSTRUCTION USING FIBULA FREE FLAP. THE SURGEONS ADJUSTED THE DISSECTED FIBULA RESULTING IN A 1-HOUR INCREASE TO SURGERY TIME. 3D SYSTEMS EMPLOYEE (B)(6) RECEIVED A CALL FROM STRYKER SALES REPRESENTATIVE (B)(6) ON 10/13/2016 STATING THAT DR. (B)(6) WAS CONFUSED AND UNHAPPY WITH THE FIBULA RECONSTRUCTION. MR. (B)(6) EXPLAINED THAT DR.(B)(6) SEEMED TO THINK THE WIDTH OF THE FIBULA RECONSTRUCTION SHOULD BE THE HEIGHT AND THE HEIGHT SHOULD BE THE WIDTH. THIS PARTICULAR FIBULA CUTTING GUIDE WAS DESIGNED WITH CUTTING SLOTS ORIENTED ON THE ANTERIOR SURFACE OF THE FIBULA, NOT UNCOMMON FOR DEFECTS OF THIS SHAPE AND SIZE AND PER THE REQUEST OF DR. (B)(6) DURING THE PLANNING SESSION. THE FIBULA CUTTING GUIDE WAS DESIGNED FO

  Patient problems: Cancer

  MAUDE report 6099540 ↗

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