NA 204.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982146281), received between Dec 12, 2017 and Apr 12, 2022 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS INVOLVED IN AN INCIDENT AT WORK THAT RESULTED IN MULTIPLE INJURIES, ONE OF WHICH WAS A FRACTURE TO HIS ARM. TO REPAIR THE FRACTURE, THE SURGEON PLACED AN IMPLANT IN THE PATIENT'S ARM. ON (B)(6) 2019, THE IMPLANT BROKE CAUSING ANOTHER FRACTURE TO THE PATIENT'S ARM. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 5 OF 17 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090001 ↗
• MalfunctionMar 10, 2022Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE 1.5 DRILL BIT AND 3.5MM CORTEX SCREW SELF-TAPPING 20MM BROKE. NO FURTHER INFORMATION PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721609 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 6MM (PART NUMBER 201.356.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM (PART NUMBER 201.362.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 16MM (PART NUMBER 201.366.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART NUMBER 201.368.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM (PART NUMBER 201.370.97, LOT UNKNOWN, QUANTITY 1), 2.0MM LCP(TM) PLATE 4 HOLES/31MM (PART NUMBER 247.344, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.8

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10442819 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 6MM (PART NUMBER 201.356.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM (PART NUMBER 201.362.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 16MM (PART NUMBER 201.366.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART NUMBER 201.368.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM (PART NUMBER 201.370.97, LOT UNKNOWN, QUANTITY 1), 2.0MM LCP(TM) PLATE 4 HOLES/31MM (PART NUMBER 247.344, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.8

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10442737 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON (B)(6) 2014, THE PATIENT SUSTAINED AN INJURY AFTER TRIPPING AND FALLING FROM A STANDING POSITION AND LANDED DIRECTLY INTO THE RIGHT ELBOW. THE PATIENT HAD THE ONSET OF PAIN AND INABILITY TO FULLY USE THE ELBOW. SUBSEQUENT X-RAYS WERE TAKEN AND REVEALED A DISPLACED, DISTRACTED OLECRANON FRACTURE, WITH A COMMINUTED RIGHT RADIAL HEAD FRACTURE. THE PATIENT ALSO COMPLAINS OF PAIN IN THE RIGHT PROXIMAL HUMERUS. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 WITH ONE (1) VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM, ONE (1) LOCKING SCREW SELF-TAPPING WITH STARD

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8692675 ↗
• InjuryJun 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. P

  Patient problems: No Code Available; Pain

  MAUDE report 8686923 ↗
• InjuryJun 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. P

  Patient problems: No Code Available; Pain

  MAUDE report 8686905 ↗
• InjuryJun 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. P

  Patient problems: No Code Available; Pain

  MAUDE report 8686860 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE AN ORTHOPEDIC REMOVAL PROCEDURE DUE TO PAIN. ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2012 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ELBOW. IT WAS NOTED THAT FRACTURE HAD ALREADY HEALED. DEVICES INVOLVED WERE ONE (1) 3.5 MM CORTEX SCREW 16MM, ONE (1) 3.5MM CORTEX SCREW 20MM, ONE (1) 3.5 MM CORTEX SCREW 24MM, ONE (1) 3.5MM CORTEX SCREW 26MM, ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, ONE (1) METAPHYSEAL SCREW, ONE (1) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM, TWO (2) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM, ONE (1) LCP POSTEROLATERAL DISTAL HEMERUS PLATE WITH LATERAL SUPPORT, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, TWO (2) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, AND ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM. ALL IMPLANTS WERE REMOVED EXCEPT FOR FOUR (4) SCREWS AS THE HEADS OF THE SCREWS WERE BROKEN OFF. IT WAS NOT DETERMINED WHICH AMONG THE SCREWS WERE

  Patient problems: Pain

  MAUDE report 8245137 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MODIFIED EVENT DESCRIPTION UPDATE: 11/16/2018 & 11/19/2018: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE LOCKING COMPRESSION (VA LCP) POSTEROLATERAL DISTAL HUMERUS PLATE, THREE (3) CORTEX SCREWS, AND THREE (3) VA LOCKING SCREWS ON OCTOBER 11, 2018 FOR A RIGHT DISTAL HUMERUS FRACTURE. DURING A POST-OPERATIVE VISIT, SURGEON DETERMINED THAT THE WHOLE CONSTRUCT FELL APART AND THERE WAS INADEQUATE FIXATION FOR THE FRACTURE TYPE. PATIENT WAS RETURNED TO SURGERY ON OCTOBER 30, 2018 WHERE SURGEON REMOVED THE IMPLANTS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8071652 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) 8 HOLE PLATE, FIVE (5) CORTEX SCREWS, TWO (2) CANNULATED SCREWS, AND ONE (1) CANCELLOUS BONE SCREW ON (B)(6) 2017 FOR REPAIR OF A BROKEN RIGHT TIBIA AND FIBULA. SURGERY WAS COMPLETED SUCCESSFULLY. IN (B)(6) 2017, PATIENT REPORTS SKIN ISSUES. IN (B)(6) 2018, PATIENT REPORTS BOTH LEGS FROM KNEE TO FOOT, FOOT AND HANDS, HAD A RASH AND SKIN IRRITATION. PATIENT WAS REFERRED TO A DERMATOLOGIST IN (B)(6) 2018. DERMATOLOGIST DETERMINED PATIENT IS ALLERGIC TO THE IMPLANTED DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Irritation

  MAUDE report 8038232 ↗
• MalfunctionOct 25, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2018, WHILE BEING IMPLANTED IN THE DISTAL HUMERUS PLATE, THE HEAD OF THE CORTEX SCREW BROKE WHILE BEING TIGHTENED. THE HEAD OF THE SCREW REMAINS IN THE PLATE. CONCOMITANT DEVICE: DISTAL HUMERUS PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8007581 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE ON (B)(6) 2018, DUE TO PAIN. DURING REMOVAL OF THE PLATE, THE SCREWDRIVER WOULD NOT DISENGAGE FROM THE SCREWDRIVER HANDLE. ANOTHER SCREWDRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A TEN (10) MINUTE DELAY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT WILL ADDRESS THE COMPLAINT ABOUT THE VA-LCP OLECRANON PLATE THAT WAS REMOVED DUE TO PAIN. THE SCREWDRIVER BLADE AND SCREWDRIVER HANDLE HAVE BEEN CAPTURED UNDER RELATED (B)(4). THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7753484 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOTOMY OF THE OLECRANON ON (B)(6) 2018 TO FIX THE HUMERUS. THE OSTEOTOMY WAS REPAIRED WITH AN OLECRANON PLATE, 2 CORTEX SCREWS, AND 4 VARIABLE ANGLE (VA) LOCKING SCREWS. ON (B)(6) 2018 THE PATIENT HAD A REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE DUE TO NON-UNION. IT WAS NOTED THAT THE PROXIMAL OLECRANON DID NOT HEAL AND THE PIECE OF BONE CAME OUT OF THE SCREW PLATE CONSTRUCT, AND PATIENT ALSO EXPERIENCED MALUNION AND DECREASED RANGE OF MOTION. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENTS' PROXIMAL OLECRANON WAS REMOVED AND THE PATIENT OUTCOME WAS STABLE. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7671430 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE VISIT (B)(6) 2017: ULCER PRESENT TO RLE (RIGHT LOWER EXTREMITY) AND PATIENT EXPERIENCING MILD PAIN, SWELLING AND ERYTHEMA. PATIENT SUSTAINED A LACERATION. HAS ENLARGED LYMPH NODES BUT NO PAIN ON WEIGHT BEARING. RIGHT INGUINAL LYMPHADENOPATHY PRESENT. RADIOGRAPHICALLY, TIBIA APPEARS TO BE PARTIALLY HEALED. FIBULA OSTEOTOMY IS HEALED. PATIENT REPORTED SHARP, INTERMITTENT, RADIATING PAIN IN HIS RIGHT LOWER LEG. PATIENT¿S VAC (RIGHT MEDIAL LEG) WAS CHANGED ON (B)(6) 2017.

  Patient problems: Unspecified Infection

  MAUDE report 7295056 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HARDWARE REMOVAL SURGERY ON (B)(6) 2017 DUE TO A REFRACTURED ANKLE. THE PATIENT ORIGINALLY UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ANKLE AND WAS IMPLANTED WITH A CANCELLOUS BONE SCREW, 3 CORTEX SCREWS, AND A TUBULAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2017. HOWEVER, SOMETIME LAST WEEK, THE PATIENT TRIPPED ON A CURB AND REFRACTURED HIS LEFT ANKLE. THE RESULTS OF THE HARDWARE REMOVAL SURGERY WERE SUCCESSFUL, THE PATIENT WAS REPORTED TO BE IN EXCELLENT CONDITION. ALL THE ORIGINALLY IMPLANTED HARDWARE WAS REPLACED WITH NEW IMPLANTS. THERE WAS NO REPORTED SURGICAL DELAY. ALL AVAILABLE INFORMATION WAS RECEIVED FROM THE SALES CONSULTANT. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7108895 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 7108507 ↗