Astra Tech Implant System® 22435Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Bridge Screw Hex · Class 1 · Implant
Quick summary
This Dentsply Astra Tech Bridge Screw Hex is a small screw used to hold together dental implants. All 35 reports describe the screw breaking, and in a few cases two implants had to be lost; the rest involved no patient symptoms, and there were 24 injuries and no deaths. No recalls name this device. Reports mentioning this identifier only appear in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07392532001765), received between Dec 18, 2025 and Sep 18, 2026 — classified as 26 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (37 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.
Reports received per month
Most reported problems
Device problems
- Fracture37
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Failure of Implant2
- Facial Paralysis1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Fracture
It was reported that a patient experienced a fracture of a dental screw. The implant is still loadable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823179 ↗InjurySep 2, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50564173 ↗InjuryApr 20, 2026Fracture
CUSTOMER REPORTED A FRACTURE OF SCREW - TWO IMPLANTS LOSS DUE TO THE FRACTURE OF SCREW. 2026-04-20 DIMBE718: CASE MIGHT BE RECLASSIFIED AFTER INVESTIGATION IS DONE.
Patient problems: Failure of Implant
MAUDE report 24927132 ↗InjuryMar 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURED BRIDGE SCREW. THE IMPLANT IS STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697289 ↗MalfunctionMar 25, 2026Fracture
IT WAS REPORTED THAT A CUSTOMER ENCOUNTERED AN IMPLANT SCREW FRACTURE. THE SCREW WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24695031 ↗MalfunctionMar 25, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL ISSUE: THE IMPLANT DRIVER PEEK HAD A FRACTURED SCREW. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693989 ↗MalfunctionMar 25, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL ISSUE: THE IMPLANT DRIVER PEEK HAD A FRACTURED SCREW. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691785 ↗InjuryMar 17, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617485 ↗InjuryMar 7, 2026Fracture
FRACTURE OF SCREWS. THE IMPLANTS ARE STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540842 ↗InjuryMar 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW. A FRACTURED SCREW WAS DETECTED WITHIN THE ABUTMENT; HOWEVER, THE IMPLANT REMAINED LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483559 ↗InjuryFeb 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED TWO FRACTURED BRIDGE SCREWS AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24374222 ↗InjuryFeb 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED TWO FRACTURED BRIDGE SCREWS AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24374219 ↗InjuryFeb 17, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368437 ↗MalfunctionFeb 17, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL ISSUE: THE IMPLANT DRIVER PEEK HAD THREE FRACTURED BRIDGE SCREWS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366797 ↗MalfunctionFeb 17, 2026Fracture
IT WAS REPORTED THAT THERE WAS THREE FRACTURED BRIDGE SCREWS ON THE TOOL (THE IMPLANT DRIVER PEEK ). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366544 ↗InjuryFeb 12, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321780 ↗InjuryFeb 6, 2026Fracture
IT WAS REPORTED THAT THE SCREW FRACTURED AND THE RESULTING FRAGMENT LED TO THE EXPLANTATION OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 24275367 ↗MalfunctionFeb 6, 2026Fracture
CUSTOMER REPORTED: SCREW FRACTURE, OCCLUSAL OVERLOAD, THE SAME PATIENT AS (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24275316 ↗InjuryFeb 4, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURED BRIDGE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24260119 ↗MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254126 ↗MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24254038 ↗MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24253150 ↗InjuryJan 23, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24160369 ↗InjuryJan 23, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24160249 ↗InjuryJan 22, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURED BRIDGE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24151596 ↗
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- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.