RapidSorbRecalls & reported problems across all models
Synthes GmbH · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one RapidSorb model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 197
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls
- 1
We found 27 models of RapidSorb by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 197 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2018 and Sep 15, 2026 — classified as 40 injuries, 157 malfunctions.
The most frequently reported specific device problem is “Break” (153 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
RapidSorb recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 24, 2024Open, Classified
Products not sterilized, sterility cannot be confirmed
Z-1238-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported RapidSorb problems
Device problems
- Break153
- Adverse Event Without Identified Device or Use Problem35
- No Apparent Adverse Event5
- Migration2
- Entrapment of Device1
- Inaccurate Information1
- Migration or Expulsion of Device1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions153
- No Code Available28
- Skin Irritation18
- Hypersensitivity/Allergic reaction12
- Reaction8
- Unspecified Infection7
- Failure of Implant4
- Inflammation3
RapidSorb models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RapidSorb 806.004.02SPLATE, BONE146 reports
- RapidSorb 530.553.01SFASTENER, PLATE, CRANIOPLASTY1 recall0 reports
- RapidSorb 805.604.10SPLATE, BONE6 reports
- RapidSorb 852.421.01SPLATE, BONE4 reports
- RapidSorb 805.603.10SPLATE, BONE4 reports
- RapidSorb 806.004.10SPLATE, BONE4 reports
- RapidSorb 852.004.01SPLATE, BONE3 reports
- RapidSorb 805.603.04SPLATE, BONE3 reports
- RapidSorb 805.606.02SPLATE, BONE3 reports
- RapidSorb 806.006.02SPLATE, BONE3 reports
- RapidSorb 851.110.01SPLATE, BONE2 reports
- RapidSorb 805.604.04SPLATE, BONE2 reports
- RapidSorb 805.605.04SPLATE, BONE2 reports
- RapidSorb 806.006.04SPLATE, BONE2 reports
- RapidSorb 851.002.01SPLATE, BONE1 report
- RapidSorb 851.008.01SPLATE, BONE1 report
- RapidSorb 851.421.01SPLATE, BONE1 report
- RapidSorb 851.611.01SPLATE, BONE1 report
- RapidSorb 851.711.01SPLATE, BONE1 report
- RapidSorb 851.721.01SPLATE, BONE1 report
- RapidSorb 851.724.01SPLATE, BONE1 report
- RapidSorb 851.801.01SCOVER, BURR HOLE1 report
- RapidSorb 852.264.01SPLATE, BONE1 report
- RapidSorb 852.343.01SPLATE, BONE1 report
- RapidSorb 805.604.02SPLATE, BONE1 report
- RapidSorb 805.605.02SPLATE, BONE1 report
- RapidSorb 805.606.04SPLATE, BONE1 report
Recent RapidSorb adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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