VARIAX 629589Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327131444), received between Mar 5, 2019 and Dec 14, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THERE IS A BREAK IN AN IMPLANTED WRIST FUSION PLATE. ORIGINAL IMPLANT DATE (B)(6) 2022. UNSURE OF THE EXACT DAY OF THE BREAK. REVISION TOOK PLACE ON (B)(6) 2022. THE PATIENT WAS CASTED THE ENTIRE TIME POST THE PRIMARY SURGERY. REASON FOR INITIAL IMPLANTATION: UNKNOWN. SCREWS CAME OUT AND FUSION PLATE WAS REMOVED, NO DEBRIS. SCREWS ARE UNAVAILABLE FOR RETURN, PLATE WILL BE THE ONLY COMPONENT RETURNED."

  Patient problems: Failure of Implant

  MAUDE report 15982713 ↗
• InjuryMay 11, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A WRIST FUSION PLATE HAD BROKEN. THE PATIENT HAD COME IN AND REPORTED THAT HIS WRIST HURT, AND SO THE PLATE AND NINE SCREW WERE REMOVED AND REPLACED WITH A COMPETITOR DEVICE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 14356972 ↗
• InjurySep 11, 2020Fracture; Fracture

  AS REPORTED: "SURGEON IMPLANTED A SHORT BEND WRIST FUSION PLATE PRODUCT NUMBER 629589, LOT#: D43822, ON (B)(6) 2019. PLATE WAS NOT BENT WHILE INSERTION. PATIENT WAS DOING WELL ALL THE WAY UP UNTIL HIS SECOND POST OP APPOINTMENT ON (B)(6) WHERE THE FUSION LOOKED GREAT. PATIENT CAME BACK TO THE OFFICE ON (B)(6) EXPERIENCING PAIN AND [SURGEON] FOUND THAT THE PATIENT EXPERIENCED A FAILURE OF HARDWARE. SURGEON SCHEDULED A WRIST FUSION CASE FOR (B)(6) AND WHILE REVIEWING X RAYS WITH HIM HE MENTIONED FOR THE FIRST TIME THE PLATE BREAKAGE AT THE TRANSVERSE HOLE AND THE PATIENTS MENTAL HEALTH. PATIENT HAS A NEUROMUSCULAR DISORDER FROM PSYCHIATRIC MEDICATIONS OR FROM A STROKE AND HIS HAND HAS MUSCLE SPASMS CAUSING HIM TO FLEX REGULARLY TO 90°. SURGEON'S PRE OP PLAN IS TO DO A TENSYNOVECTOMY OF EXTENSOR TENDONS AND ASSESS BONE QUALITY AND PLATE. WE IMPLANTED THE SAME PRODUCT #629589, LOT#: D54200 WITH THE SAME SCREW PATTERNS AND SIZES WHILE FUSING THE CMC JOINT AND UTILIZING BONE GRAFT."

  Patient problems: Failure of Implant; Implant Pain; Injury; Pain

  MAUDE report 10525163 ↗
• InjuryApr 15, 2020Fracture; Fracture

  IT WAS REPORTED, PATIENT HAD LEFT WRIST SURGERY IN (B)(6) 2017, HE HAS BEEN EXPERIENCING BURNING. PATIENT HAD X-RAY THAT SHOWED BROKEN PLATE. REVISION SURGERY OCCURRED.

  Patient problems: Burning Sensation; Failure of Implant; Injury

  MAUDE report 9965231 ↗
• InjuryMar 5, 2019Break; Fracture; Fracture

  CUSTOMER REPORTED THAT A VARIAX WRIST FUSION PLATE HAS BROKEN AND WILL BE REMOVED ON (B)(6).

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8392630 ↗