DIGITALIS Spacer MCP – SIZE 4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08057717554540), received between Oct 8, 2024 and Oct 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT IS A 73-YEAR-OLD MALE WHO PREVIOUSLY HAD AN EXTENSOR TENDON REALIGNMENT AND SUBSEQUENTLY HAS WORSENING OF HIS ARTHRITIS. HE WAS SUBMITTED TO MP JOINT SILICONE ARTHROPLASTIES AND EXTENSOR TENDON REALIGNMENT TO 4 FINGERS OF THE LEFT HAND (INDEX, LONG, RING AND SMALL FINGER. THE SURGICAL INTERVENTION HAPPENED ON (B)(6) 2024. THE OPERATING PROCEDURE STATES THAT THE EXTENSOR TENDONS TO THE LONG, RING AND SMALL FINGER, EDC AND EDM WERE DENSELY STUCK IN SCAR TISSUE FROM PRIOR SURGERY, SO THE SURGEON HAD TO PERFORM AN EXTENSIVE TENOLYSIS ON ALL FOUR TENDONS. THE IMPLANTS WERE THEN IMPLANTED. A WEEK AFTER SURGERY, THE PATIENT STATES THAT ALL THE IMPLANTS ARE DISLOCATED. THE PATIENT CLAIMS USING A RIGID SPINT SINCE SURGERY. AFTER THE ANALYSIS OF THE RELEVANT DOCUMENTATION AND X-RAYS AND CONSULTATION WITH A CLINICAL EXPERT, THE MANUFACTURER IDENTIFIED SOFT TISSUE INSTABILITY AS THE REASON FOR THE DISLOCATION. THIS IS REPORT 2 OF 4.

  Patient problems: Joint Dislocation

  MAUDE report 20395101 ↗
• InjuryOct 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT IS A 73-YEAR-OLD MALE WHO PREVIOUSLY HAD AN EXTENSOR TENDON REALIGNMENT AND SUBSEQUENTLY HAS WORSENING OF HIS ARTHRITIS. HE WAS SUBMITTED TO MP JOINT SILICONE ARTHROPLASTIES AND EXTENSOR TENDON REALIGNMENT TO 4 FINGERS OF THE LEFT HAND (INDEX, LONG, RING AND SMALL FINGER. THE SURGICAL INTERVENTION HAPPENED ON (B)(6) 2024. THE OPERATING PROCEDURE STATES THAT THE EXTENSOR TENDONS TO THE LONG, RING AND SMALL FINGER, EDC AND EDM WERE DENSELY STUCK IN SCAR TISSUE FROM PRIOR SURGERY, SO THE SURGEON HAD TO PERFORM AN EXTENSIVE TENOLYSIS ON ALL FOUR TENDONS. THE IMPLANTS WERE THEN IMPLANTED. A WEEK AFTER SURGERY, THE PATIENT STATES THAT ALL THE IMPLANTS ARE DISLOCATED. THE PATIENT CLAIMS USING A RIGID SPINT SINCE SURGERY. AFTER THE ANALYSIS OF THE RELEVANT DOCUMENTATION AND X-RAYS AND CONSULTATION WITH A CLINICAL EXPERT, THE MANUFACTURER IDENTIFIED SOFT TISSUE INSTABILITY AS THE REASON FOR THE DISLOCATION. THIS IS REPORT 3 OF 4.

  Patient problems: Joint Dislocation

  MAUDE report 20395086 ↗