NA 204.665Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982146052), received between Jan 12, 2021 and Apr 17, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AROUND (B)(6) 2020 THE PATIENT FELL FROM A SCAFFOLDING AND INJURED HIS RIGHT KNEE. THE CT SCAN REVEALED A COMMINUTED BICONDYLAR TIBIAL PLATEAU FRACTURE. AROUND (B)(6) 2020 THE PATIENT UNDERWENT RIGHT TIBIAL ORIF WITH MEDIAL POSTEROMEDIAL PLATING, MEDIAL AND LATERAL MENISCAL REPAIR AND A PROPHYLACTIC 4 COMPARTMENT FASCIOTOMY. THE SURGEON IMPLANTED A PROXIMAL ANTEROLATERAL SYNTHES TIBIAL PLATEAU LOCKING PLATE AND ONE 3.5 POSTEROMEDIAL TIBIAL T PLATE WITH ASSOCIATED SCREWS. THE SURGEON ALSO UTILIZED A SINGLE-USE DRILL BIT. FOLLOWING THE SURGERY OF (B)(6) 2020 THE PATIENT PERFORMED REHABILITATION AND THERAPY AS RECOMMENDED BY HIS MEDICAL PROVIDERS. HOWEVER, HE CONTINUED TO EXPERIENCE PAIN, DISCOMFORT, AND FUNCTIONAL LIMITATIONS IN HIS RIGHT KNEE. ALSO HE EXPERIENCED PROBLEMS WITH WOUND HEALING, INCLUDING INCREASED PAIN, SWELLING, AND DRAINAGE FROM THE INCISION SITE. AROUND (B)(6) 2020 THE PATIENT DIAGNOSED WITH SEPTIC ARTHRITIS. IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO ADDITIONAL SURGERY FOR HIS WOUND COMPLICATIONS, INCLUDING ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF HIS MEDIAL AND LATERAL INCISIONS ALONG WITH THE REMOVAL OF ALL HIS HARDWARE AND THE INSTAL

  Patient problems: Discomfort; Impaired Healing; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16753338 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A SURGERY TO REMOVE HARDWARE DUE TO PAIN. THE PATIENT HAD SOME PAINFUL HARDWARE AFTER BONE HEALING AND THUS REQUESTED IT BE REMOVED IF HEALING WAS COMPLETED. THE HEALING WAS COMPLETED, SO NO LONGER NEEDED HARDWARE WAS REMOVED. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 65MM. THIS REPORT IS 8 OF 9 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11156069 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A SURGERY TO REMOVE HARDWARE DUE TO PAIN. THE PATIENT HAD SOME PAINFUL HARDWARE AFTER BONE HEALING AND THUS REQUESTED IT BE REMOVED IF HEALING WAS COMPLETED. THE HEALING WAS COMPLETED, SO NO LONGER NEEDED HARDWARE WAS REMOVED. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) 3.5MM PELVIC CORTEX SCREW SELF-TAPPING 65MM THIS REPORT IS 3 OF 9 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11156026 ↗