PEEK IntraLineRecalls & reported problems across all models
Stryker Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of PEEK IntraLine by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2020 and Oct 21, 2025 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Break” (16 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. 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
Most reported PEEK IntraLine problems
Device problems
- Break16
- Material Fragmentation14
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Insufficient Information4
- No Known Impact Or Consequence To Patient2
PEEK IntraLine models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PEEK IntraLine 3910-400-010Screw, fixation, bone21 reports
- PEEK IntraLine 3910-400-015Screw, fixation, bone6 reports
Recent PEEK IntraLine adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE PROXIMAL END OF THE ANCHOR BROKE DURING INSERTION AT THE POINT WHERE THE ANCHOR INSERTER ENDS IN THE ANCHOR. A NEW ANCHOR WAS USED TO COMPLETE THE PROCEDURE. ALL BROKEN PARTS WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23353123 ↗MalfunctionOct 21, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE PROXIMAL END OF THE ANCHOR BROKE DURING INSERTION AT THE POINT WHERE THE ANCHOR INSERTER ENDS IN THE ANCHOR. A NEW ANCHOR WAS USED TO COMPLETE THE PROCEDURE. ALL BROKEN PARTS WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23353122 ↗MalfunctionOct 21, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE PROXIMAL END OF THE ANCHOR BROKE DURING INSERTION AT THE POINT WHERE THE ANCHOR INSERTER ENDS IN THE ANCHOR. A NEW ANCHOR WAS USED TO COMPLETE THE PROCEDURE. ALL BROKEN PARTS WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351123 ↗MalfunctionSep 10, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS BREAKAGE OF PEEK PART OF PEEK INTRALINE ANCHOR POST DRILLING AND TAPPING. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23022295 ↗MalfunctionSep 10, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS BREAKAGE OF PEEK PART OF PEEK INTRALINE ANCHOR POST DRILLING AND TAPPING. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23022294 ↗MalfunctionSep 10, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS BREAKAGE OF PEEK PART OF PEEK INTRALINE ANCHOR POST DRILLING AND TAPPING. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23022286 ↗MalfunctionJun 5, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHILE PLACING IN THE ANCHOR POST TAPPING WHILE FIXATING THE SCREW STARTED TO PULL OFF. THIS WAS A BREAKAGE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22154558 ↗MalfunctionOct 2, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20355605 ↗MalfunctionOct 2, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20355599 ↗MalfunctionAug 23, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20055547 ↗MalfunctionAug 15, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17552569 ↗MalfunctionAug 15, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17552566 ↗MalfunctionAug 8, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17484509 ↗MalfunctionAug 7, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17476062 ↗MalfunctionJul 27, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17402934 ↗
Other Stryker Corporation products
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- Prime Series21 models · 1,548 reports · 2 recalls
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- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
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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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