SMARTLOCKRecalls & reported problems across all models
Stryker Leibinger GmbH & Co. KG · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 64
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls
- 0
We found 17 models of SMARTLOCK by Stryker Leibinger GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Sep 16, 2026 — classified as 46 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Fracture” (30 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 SMARTLOCK problems
Device problems
- Fracture30
- Adverse Event Without Identified Device or Use Problem22
- Device Appears to Trigger Rejection14
- Break3
- Contamination3
- Material Deformation2
- No Apparent Adverse Event2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Unspecified Infection24
- Insufficient Information5
- No Known Impact Or Consequence To Patient5
- Fistula3
- No Code Available2
- Erythema1
- Failure of Implant1
SMARTLOCK models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SMARTLOCK 55-10554PLATE, BONE30 reports
- SMARTLOCK 55-10556PLATE, BONE16 reports
- SMARTLOCK 55-10566PLATE, BONE2 reports
- SMARTLOCK 52-20504PLATE, BONE2 reports
- SMARTLOCK 50-20512PLATE, BONE2 reports
- SMARTLOCK 55-05758PLATE, BONE1 report
- SMARTLOCK 55-05763PLATE, BONE1 report
- SMARTLOCK 55-05765PLATE, BONE1 report
- SMARTLOCK 55-05767PLATE, BONE1 report
- SMARTLOCK 55-10564PLATE, BONE1 report
- SMARTLOCK 52-20505PLATE, BONE1 report
- SMARTLOCK 50-20598SCREW, FIXATION, INTRAOSSEOUS1 report
- SMARTLOCK 55-02950PLATE, BONE1 report
- SMARTLOCK 50-20514PLATE, BONE1 report
- SMARTLOCK 50-23508PLATE, BONE1 report
- SMARTLOCK 50-23510PLATE, BONE1 report
- SMARTLOCK 50-23514PLATE, BONE1 report
Recent SMARTLOCK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Device Appears to Trigger Rejection
It was reported that an infection has occurred.
Patient problems: Insufficient Information
MAUDE report 50785779 ↗InjuryMay 28, 2026Fracture
IT WAS REPORTED THAT THE PLATE WAS FRACTURED AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313381 ↗InjuryApr 30, 2026Fracture
IT WAS REPORTED THAT THE IMPLANTED PLATE WAS BROKEN AND A REVISION SURGERY IS NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25043174 ↗InjuryApr 29, 2026Device Appears to Trigger Rejection
IT WAS REPORTED THAT THERE WAS AN INFECTION WHEN THE PLATE WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 25027043 ↗InjuryApr 13, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DISCHARGE WAS OBSERVED ON BOTH SIDES OF THE LOWER JAW DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24857519 ↗InjuryApr 10, 2026Fracture
IT WAS REPORTED THAT THE PLATE BROKE AFTER THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844265 ↗InjuryApr 9, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE IMPLANTED PLATES.
Patient problems: Unspecified Infection
MAUDE report 24829618 ↗InjuryApr 2, 2026Fracture
No new information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767823 ↗InjuryMar 5, 2026Fracture
No new information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523649 ↗InjuryMar 5, 2026Fracture
IT WAS REPORTED THAT A PLATE FRACTURE WAS IDENTIFIED, AND REVISION SURGERY IS SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523623 ↗InjuryFeb 19, 2026Fracture
IT WAS REPORTED THAT POSTOPERATIVELY, A FRACTURE OF THE MANDIBULAR LOCKING SAGITTAL PLATE OCCURRED, REQUIRING REMOVAL SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388501 ↗InjuryFeb 6, 2026Fracture
No new information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278020 ↗InjuryDec 18, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryDec 18, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
InjuryDec 18, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
Other Stryker Leibinger GmbH & Co. KG products
All Stryker Leibinger GmbH & Co. KG 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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