TAMINA 3.5mm Proximal Humerus Plate, TF, 5 Hole, Right B-122110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640187461343), received between Aug 9, 2024 and Nov 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, DR.(B)(6) ,(B)(6) REPORTED A CASE OF SCREW LOOSENING AND PULL-THROUGH TO BONEBRIDGE. THE PATIENT, AGED 78 AND WEIGHING 104 KG, HAD BEEN TREATED WITH A 3.5 MM TAMINA PROXIMAL HUMERUS PLATE TF, 5-HOLE, RIGHT IN (B)(6). AT THE THREE-MONTH FOLLOW-UP, ALL DISTAL SCREWS HAD LOOSENED AND THE MOST DISTAL SCREW HAD PULLED THROUGH THE PLATE. ACCORDING TO THE SURGEON, THE PATIENT FELL WITHIN THE SIX-WEEK POST-OPERATIVE CARE PERIOD AND WAS NON-COMPLIANT, FAILING TO CONSISTENTLY WEAR THE PRESCRIBED SLING. SIGNS OF RECONSTRUCTION FAILURE WERE VISIBLE AFTER SIX WEEKS. BONEBRIDGE WAS ONLY INFORMED OF THE INCIDENT AFTER THE THREE-MONTH FOLLOW-UP. REVISION SURGERY IS NOT CURRENTLY PLANNED, BUT THIS REMAINS A POSSIBILITY DEPENDING ON THE PROGRESS OF THE HEALING PROCESS AT THE SIX-MONTH FOLLOW-UP. DUE TO CONCERNS REGARDING THE FIXATION TECHNIQUE, THE CASE WAS REVIEWED INDEPENDENTLY BY AN ORTHOPEDIC SURGEON FROM THE BONEBRIDGE TECHNICAL COMMISSION. THE ORIGIN OF THE CASE WAS BLINDED TO THE REVIEWER WHO PROVIDED THE FOLLOWING FEEDBACK: PREOPERATIVE REDUCTION WAS SUBOPTIMAL, LEADING TO VARUS MALALIGNMENT AND COMPROMISED STABILITY. CONSTRUCT DESIGN: THE OBLONG-HOLE SCREW WAS NOT ANGULAR-ST

  Patient problems: Bone Fracture(s)

  MAUDE report 23485928 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGERY DATE: (B)(6) 2024. ON (B)(6) 2024 SURGERY ON A PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON A 44Y OLD, MALE OVERWEIGHT (331LB/150KG) PATIENT. THE PATIENT WAS POLYTRAUMATIZED WITH ADDITIONAL LOWER EXTREMITY FRACTURES. THE SURGERY WAS UNEVENTFUL AND FRACTURE REDUCTION COULD BE ACHIEVED. FOR POSTOPERATIVE RECOVERY THE PATIENT HAD TO BE PLACED IN A WHEEL CHAIR DUE TO HIS LOWER EXTREMITY INJURIES, SUGGESTING THAT FULL IMMOBILIZATION OF THE HUMERUS MAY NOT HAVE BEEN ACHIEVED. FURTHERMORE, ACCORDING TO THE TREATING SURGEON, PATIENT NON-COMPLIANCE IS HIGHLY LIKELY. THE PATIENT WAS FOLLOWED UP 2 WEEKS AFTER SURGERY AND THE RADIOLOGICAL ASSESSMENT SHOWED UNEVENTFUL PROGRESS. 7 WEEKS POSTOPERATIVELY THE PATIENT WAS FOLLOWED UP AGAIN. THE RADIOLOGICAL ASSESSMENT REVEALED ONLY MINIMAL BONY CONSOLIDATION (NON-UNION) AND PULL-OUT OF THE TWO MOST DISTAL VA-LOCKING SCREWS WAS VISIBLE. BONEBRIDGE BECAME AWARE OF THIS EVENT ON JULY 10, 2024. A CT SCAN WAS PERFORMED TO FURTHER INVESTIGATE THE PROGRESS OF BONE HEALING; MINIMAL BONE HEALING WAS CONFIRMED BUT INITIALLY NO REVISION SURGERY WAS PLANNED AND THE PATIENT IMMOBILIZED. FURTHER RADIOLOGICAL EVALUATION AFTER ANOTHER TWO WEEKS SHOWED PERSIST

  Patient problems: Limb Fracture

  MAUDE report 19949067 ↗