NA 04.315.744.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587072180), received between May 7, 2020 and May 7, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE TO RE-POSITION THE CMF-DISTRACTOR FOR BONE SCREW LOOSENING IN THE POSTERIOR FOOTPLATE. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WHICH CONSIST OF ONE (1) 1.0MM MESH FOOT B-TYPE, ONE (1) 1.0MM MESH FOOT C-TYPE, 15MM BC DISTRACTOR, ONE (1) 30MM REMOVAL EXTENSION ARMS AND SEVEN (7) 1.3MM TITANIUM RAISED HEAD SCREWS WERE ALL EXPLANTED AND A NEW IMPLANT WAS IMPLANTED AND NEEDED TO BE REPOSITIONED DUE TO THE CHALLENGING BONY ANATOMY OF THE PATIENT. NO X-RAYS WERE INVOLVED IN THIS PROCEDURE. THE PATIENT IS A NEONATE AND AS THE PATIENT WAS UNDERGOING DISTRACTION POST OPERATIVELY THE SURGEON BELIEVED HE COULD GET BETTER RESULTS BY ADJUSTING THE POSITION ON THE DISTRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR (PART # 04.315.202, LOT # UNKNOWN, QUANTITY 1), 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR (PART # 04.315.203, LOT # UNKNOWN, QUANTITY 1), BC DISTRACTOR BODY END ACT. (PART # 04.315.023, LOT # UNKNOWN, QUANTITY 1), REMOVABLE EXTENSION ARM-FLEX (PART # 04.315.125, LOT # UN

  Patient problems: No Code Available

  MAUDE report 10036493 ↗
• InjuryMay 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE TO RE-POSITION THE CMF-DISTRACTOR FOR BONE SCREW LOOSENING IN THE POSTERIOR FOOTPLATE. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WHICH CONSIST OF ONE (1) 1.0MM MESH FOOT B-TYPE, ONE (1) 1.0MM MESH FOOT C-TYPE, 15MM BC DISTRACTOR, ONE (1) 30MM REMOVAL EXTENSION ARMS AND SEVEN (7) 1.3MM TITANIUM RAISED HEAD SCREWS WERE ALL EXPLANTED AND A NEW IMPLANT WAS IMPLANTED AND NEEDED TO BE REPOSITIONED DUE TO THE CHALLENGING BONY ANATOMY OF THE PATIENT. NO X-RAYS WERE INVOLVED IN THIS PROCEDURE. THE PATIENT IS A NEONATE AND AS THE PATIENT WAS UNDERGOING DISTRACTION POST OPERATIVELY THE SURGEON BELIEVED HE COULD GET BETTER RESULTS BY ADJUSTING THE POSITION ON THE DISTRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR (PART # 04.315.202, LOT # UNKNOWN, QUANTITY 1), 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR (PART # 04.315.203, LOT # UNKNOWN, QUANTITY 1), BC DISTRACTOR BODY END ACT. (PART # 04.315.023, LOT # UNKNOWN, QUANTITY 1), REMOVABLE EXTENSION ARM-FLEX (PART # 04.315.125, LOT # UN

  Patient problems: No Code Available

  MAUDE report 10036489 ↗
• InjuryMay 7, 2020Adverse 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 A REVISION PROCEDURE TO RE-POSITION THE CMF-DISTRACTOR FOR BONE SCREW LOOSENING IN THE POSTERIOR FOOTPLATE. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WHICH CONSIST OF ONE (1) 1.0MM MESH FOOT B-TYPE, ONE (1) 1.0MM MESH FOOT C-TYPE, 15MM BC DISTRACTOR, ONE (1) 30MM REMOVAL EXTENSION ARMS AND SEVEN (7) 1.3MM TITANIUM RAISED HEAD SCREWS WERE ALL EXPLANTED AND A NEW IMPLANT WAS IMPLANTED AND NEEDED TO BE REPOSITIONED DUE TO THE CHALLENGING BONY ANATOMY OF THE PATIENT. NO X-RAYS WERE INVOLVED IN THIS PROCEDURE. THE PATIENT IS A NEONATE AND AS THE PATIENT WAS UNDERGOING DISTRACTION POST OPERATIVELY THE SURGEON BELIEVED HE COULD GET BETTER RESULTS BY ADJUSTING THE POSITION ON THE DISTRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR (PART # 04.315.202, LOT # UNKNOWN, QUANTITY 1), 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR (PART # 04.315.203, LOT # UNKNOWN, QUANTITY 1), BC DISTRACTOR BODY END ACT. (PART # 04.315.023, LOT # UNKNOWN, QUANTITY 1), REMOVABLE EXTENSION ARM-FLEX (PART # 04.315.125, LOT # UN

  Patient problems: No Code Available

  MAUDE report 10036478 ↗
• InjuryMay 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE TO RE-POSITION THE CMF-DISTRACTOR FOR BONE SCREW LOOSENING IN THE POSTERIOR FOOTPLATE. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WHICH CONSIST OF ONE (1) 1.0MM MESH FOOT B-TYPE, ONE (1) 1.0MM MESH FOOT C-TYPE, 15MM BC DISTRACTOR, ONE (1) 30MM REMOVAL EXTENSION ARMS AND SEVEN (7) 1.3MM TITANIUM RAISED HEAD SCREWS WERE ALL EXPLANTED AND A NEW IMPLANT WAS IMPLANTED AND NEEDED TO BE REPOSITIONED DUE TO THE CHALLENGING BONY ANATOMY OF THE PATIENT. NO X-RAYS WERE INVOLVED IN THIS PROCEDURE. THE PATIENT IS A NEONATE AND AS THE PATIENT WAS UNDERGOING DISTRACTION POST OPERATIVELY THE SURGEON BELIEVED HE COULD GET BETTER RESULTS BY ADJUSTING THE POSITION ON THE DISTRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR (PART # 04.315.202, LOT # UNKNOWN, QUANTITY 1), 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR (PART # 04.315.203, LOT # UNKNOWN, QUANTITY 1), BC DISTRACTOR BODY END ACT. (PART # 04.315.023, LOT # UNKNOWN, QUANTITY 1), REMOVABLE EXTENSION ARM-FLEX (PART # 04.315.125, LOT # UN

  Patient problems: No Code Available

  MAUDE report 10036477 ↗
• InjuryMay 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE TO RE-POSITION THE CMF-DISTRACTOR FOR BONE SCREW LOOSENING IN THE POSTERIOR FOOTPLATE. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WHICH CONSIST OF ONE (1) 1.0MM MESH FOOT B-TYPE, ONE (1) 1.0MM MESH FOOT C-TYPE, 15MM BC DISTRACTOR, ONE (1) 30MM REMOVAL EXTENSION ARMS AND SEVEN (7) 1.3MM TITANIUM RAISED HEAD SCREWS WERE ALL EXPLANTED AND A NEW IMPLANT WAS IMPLANTED AND NEEDED TO BE REPOSITIONED DUE TO THE CHALLENGING BONY ANATOMY OF THE PATIENT. NO X-RAYS WERE INVOLVED IN THIS PROCEDURE. THE PATIENT IS A NEONATE AND AS THE PATIENT WAS UNDERGOING DISTRACTION POST OPERATIVELY THE SURGEON BELIEVED HE COULD GET BETTER RESULTS BY ADJUSTING THE POSITION ON THE DISTRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR (PART # 04.315.202, LOT # UNKNOWN, QUANTITY 1), 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR (PART # 04.315.203, LOT # UNKNOWN, QUANTITY 1), BC DISTRACTOR BODY END ACT. (PART # 04.315.023, LOT # UNKNOWN, QUANTITY 1), REMOVABLE EXTENSION ARM-FLEX (PART # 04.315.125, LOT # UN

  Patient problems: No Code Available

  MAUDE report 10036470 ↗
• InjuryMay 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE TO RE-POSITION THE CMF-DISTRACTOR FOR BONE SCREW LOOSENING IN THE POSTERIOR FOOTPLATE. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WHICH CONSIST OF ONE (1) 1.0MM MESH FOOT B-TYPE, ONE (1) 1.0MM MESH FOOT C-TYPE, 15MM BC DISTRACTOR, ONE (1) 30MM REMOVAL EXTENSION ARMS AND SEVEN (7) 1.3MM TITANIUM RAISED HEAD SCREWS WERE ALL EXPLANTED AND A NEW IMPLANT WAS IMPLANTED AND NEEDED TO BE REPOSITIONED DUE TO THE CHALLENGING BONY ANATOMY OF THE PATIENT. NO X-RAYS WERE INVOLVED IN THIS PROCEDURE. THE PATIENT IS A NEONATE AND AS THE PATIENT WAS UNDERGOING DISTRACTION POST OPERATIVELY THE SURGEON BELIEVED HE COULD GET BETTER RESULTS BY ADJUSTING THE POSITION ON THE DISTRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR (PART # 04.315.202, LOT # UNKNOWN, QUANTITY 1), 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR (PART # 04.315.203, LOT # UNKNOWN, QUANTITY 1), BC DISTRACTOR BODY END ACT. (PART # 04.315.023, LOT # UNKNOWN, QUANTITY 1), REMOVABLE EXTENSION ARM-FLEX (PART # 04.315.125, LOT # UN

  Patient problems: No Code Available

  MAUDE report 10036468 ↗
• InjuryMay 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE TO RE-POSITION THE CMF-DISTRACTOR FOR BONE SCREW LOOSENING IN THE POSTERIOR FOOTPLATE. DURING THE REVISION PROCEDURE THE ORIGINAL IMPLANTS WHICH CONSIST OF ONE (1) 1.0MM MESH FOOT B-TYPE, ONE (1) 1.0MM MESH FOOT C-TYPE, 15MM BC DISTRACTOR, ONE (1) 30MM REMOVAL EXTENSION ARMS AND SEVEN (7) 1.3MM TITANIUM RAISED HEAD SCREWS WERE ALL EXPLANTED AND A NEW IMPLANT WAS IMPLANTED AND NEEDED TO BE REPOSITIONED DUE TO THE CHALLENGING BONY ANATOMY OF THE PATIENT. NO X-RAYS WERE INVOLVED IN THIS PROCEDURE. THE PATIENT IS A NEONATE AND AS THE PATIENT WAS UNDERGOING DISTRACTION POST OPERATIVELY THE SURGEON BELIEVED HE COULD GET BETTER RESULTS BY ADJUSTING THE POSITION ON THE DISTRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR (PART # 04.315.202, LOT # UNKNOWN, QUANTITY 1), 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR (PART # 04.315.203, LOT # UNKNOWN, QUANTITY 1), BC DISTRACTOR BODY END ACT. (PART # 04.315.023, LOT # UNKNOWN, QUANTITY 1), REMOVABLE EXTENSION ARM-FLEX (PART # 04.315.125, LOT # UN

  Patient problems: No Code Available

  MAUDE report 10033500 ↗