Z5-BL Z5-BL-3612Recalls & reported problems
Z-Systems AG · Implant + TP-SNS + BL-HC · Class 2 · Implant
All models of Z5-BL (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07640166768524), received between Aug 12, 2024 and Sep 30, 2026 — classified as 4 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate18
- Loss of Osseointegration3
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Inflammation6
- Unspecified Tissue Injury3
- Unspecified Infection2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943213 ↗MalfunctionJun 24, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608905 ↗MalfunctionMay 26, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276640 ↗MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203029 ↗MalfunctionMay 18, 2026Failure to Osseointegrate
MalfunctionMar 30, 2026Fracture
MalfunctionMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702092 ↗MalfunctionJan 22, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148978 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826971 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278225 ↗MalfunctionAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionAug 26, 2025Fracture; Fracture
MalfunctionAug 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionAug 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionMay 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061020 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21932511 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION, SEEMS THAT AN INFECTION HAS OCCURED, PREVENTING OSSEOINTEGRATION.
Patient problems: Inflammation
MAUDE report 21932509 ↗MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616429 ↗MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616422 ↗InjuryAug 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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