RapidSorb 806.004.02SRecalls & reported problems
Synthes GmbH · 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE · Class 2 · Implant
All models of RapidSorb (27)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes RapidSorb screw is a dissolving screw used to fix bone in place. Most reports describe the screw breaking, often during insertion in surgery. The 157 reports include no deaths and no injuries. No recalls name this device, and reports rose from 54 in the prior 12 months to 91 in the latest 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
- 146
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 20887587061815), received between Jan 27, 2022 and Sep 15, 2026 — classified as 146 malfunctions.
The most frequently reported specific device problem is “Break” (143 reports).
3 other recalls cover devices cleared under the same FDA submission (K030069, K062789); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Break143
- No Apparent Adverse Event3
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions145
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775827 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50522837 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495440 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495438 ↗MalfunctionAug 28, 2026Break
It was reported during the surgery, when inserting the screw, the screw was broke. All the pieces were removed from the patient. Changed to another eight to continue the surgery, the same problem happened again. Total involved nine screws. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495432 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495429 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495428 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495426 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495388 ↗MalfunctionJun 23, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25593945 ↗MalfunctionJun 23, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25593912 ↗MalfunctionJun 16, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522470 ↗MalfunctionJun 16, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522467 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25380991 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25379029 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25378043 ↗MalfunctionMay 28, 2026Break
IT WAS REPORTED THAT DURING A NEUROSURGERY SKULL CLOSURE SURGERY, TWO SCREWS WERE BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317039 ↗MalfunctionApr 27, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999489 ↗MalfunctionApr 10, 2026Break
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? - NO. B. WAS OTHER MEDICAL INTERVENTION REQUIRED? - NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844898 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779860 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779842 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER SCREW TO CONTINUE THE SURGERY. THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24745066 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER SCREW TO CONTINUE THE SURGERY. THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24745064 ↗MalfunctionMar 20, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, NOTED THE SCREW THREADS PEELED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649529 ↗MalfunctionFeb 10, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERT THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24303054 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K030069, K062789. One submission often covers many models, so check the product and lot details in each record.
- Z-1920-2016 · May 2, 2016 · Terminated1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intend
- Z-1918-2016 · May 2, 2016 · Terminated1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Inte
- Z-1919-2016 · May 2, 2016 · Terminated1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intend
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 reports
- 2.4MM SYSTEM 91-2710Biomet Microfixation, Inc · Plate, Bone37 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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