OsteoSurge 300 Putty 56500100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981055851), received between Jul 29, 2016 and Jul 29, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2016Patient-Device Incompatibility; Patient-Device Incompatibility

  INITIAL PLF SURGERY ON (B)(6) 2016 TO ADDRESS LEFT LEG PAIN, INVOLVED DIRECT DECOMPRESSION OF THE THECAL SAC, PLACEMENT OF GLOBUS PEDICLE SCREW SYSTEM CONSTRUCT FROM L4 TO S1, AND POSTEROLATERAL GUTTER FUSION CONSISTING OF BMAC (BONE MARROW ASPIRATE CONCENTRATE) MIXED WITH HEPARIN AND BONE VOID FILLER PUTTY PLACED IN THE LATERAL GUTTERS. PATIENT WAS ASYMPTOMATIC AND WALKING IMMEDIATE POST-OPERATIVELY. EVENT: THIRD DAY POST-OPERATIVELY THE PATIENT HAD PAIN AND NUMBNESS IN THE RIGHT LEG. UPON EVALUATION OF THE MRI IT WAS DETERMINED THAT THE THECAL SAC WAS COMPRESSED BY A POSSIBLE HEMATOMA/ SEROMA (POSSIBLE CAUSE OF THE NEUROLOGICAL DEFICIT.) DURING REVISION, NO HEMATOMA WAS FOUND, BUT INFLAMMATION OF THE AREA WAS OBSERVED AND GRAFT WAS OBSERVED TO HAVE A GELATIN CONSISTENCY AND NEAR THE NERVE. REVISION WAS PERFORMED REMOVING 50% OF THE POSTEROLATERAL FUSION MATERIAL NEAR THE THECAL SAC. ON THE FIFTH DAY AN ADDITIONAL MRI SCAN WAS PERFORMED AND IT DEPICTED A REOCCURRING SEROMA IN THE SAME AREA. PATIENT OUTCOME: PATIENT CURRENT HAVING LEG PAIN IN BOTH LEGS AND NUMBNESS IN THE FEET, POST REVISION. SURGEON IS EVALUATING PATIENT AND A SECOND REVISION WAS PLANNED FOR (B)(6) 2016.

  Patient problems: Neurological Deficit/Dysfunction; Pain

  MAUDE report 5835393 ↗