LEVEL ONE ORTHOANCHORRecalls & reported problems across all models
KLS-Martin L.P. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 15 models of LEVEL ONE ORTHOANCHOR by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2017 and Nov 19, 2024 — classified as 20 injuries.
The most frequently reported specific device problem is “Break” (13 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 LEVEL ONE ORTHOANCHOR problems
Device problems
- Break13
- Off-Label Use4
- Material Separation2
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Material Fragmentation1
Patient problems
- Impaired Healing12
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Code Available1
- No Consequences Or Impact To Patient1
LEVEL ONE ORTHOANCHOR models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LEVEL ONE ORTHOANCHOR 25-301-35-09IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- LEVEL ONE ORTHOANCHOR 25-301-04-09IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- LEVEL ONE ORTHOANCHOR 25-301-20-09IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- LEVEL ONE ORTHOANCHOR 25-301-34-09IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- LEVEL ONE ORTHOANCHOR 00-301-12-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 01-301-05-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 01-301-06-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 25-301-02-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 25-301-17-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 25-301-22-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 25-301-31-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 25-301-36-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 50-340-08-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 50-340-11-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- LEVEL ONE ORTHOANCHOR 50-345-15-09IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent LEVEL ONE ORTHOANCHOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 19, 2024Off-Label Use; Off-Label Use
IT WAS REPORTED A PLATE BROKE DUE TO AN OFF-LABEL USE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 20727220 ↗InjuryJan 17, 2024Off-Label Use; Off-Label Use
AN ORTHOANCHOR PLATE USED IN OFF-LABEL USE BOLLARD TECHNIQUE APPLICATION FRACTURED UNDER LOAD. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 18530400 ↗InjuryJan 28, 2022Break; Break
IT WAS REPORTED THAT AN ORTHOANCHOR PLATE BROKE. IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 13388447 ↗InjuryDec 8, 2021Off-Label Use; Material Separation; Off-Label Use; Material Separation
IT WAS REPORTED THAT A PLATE BROKE IN AN OFF-LABEL PROCEDURE. PLATE WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 12964320 ↗InjuryOct 29, 2021Off-Label Use; Material Separation; Off-Label Use; Material Separation
IT WAS REPORTED THAT A PLATE BROKE IN AN OFF-LABEL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 12722973 ↗InjuryAug 20, 2021Break; Break
IT WAS REPORTED THE PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 12348142 ↗InjuryJul 2, 2021Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 12111999 ↗InjuryDec 16, 2019Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9476815 ↗InjuryDec 16, 2019Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9476806 ↗InjuryAug 15, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8896913 ↗InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PLATE BECAME LOOSE AND WAS REPLACED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8789570 ↗InjuryApr 9, 2019Break; Break
IT WAS REPORTED A SCREW BROKE DURING IMPLANTATION. ALL PIECES WERE REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8496394 ↗InjuryAug 24, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE. THE BROKEN PLATE WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 7812531 ↗InjuryAug 17, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE. AN ATTEMPT TO REMOVE THE PLATE WAS MADE; HOWEVER, IT REMAINS IMPLANTED DUE TO BONE OVERGROWTH.
Patient problems: Impaired Healing
MAUDE report 7793990 ↗InjuryApr 27, 2018Break; Break
IT WAS REPORTED THE ORTHO-ANCHOR PLATE BROKE. PLATE WAS REMOVED AND REPLACED ON (B)(6) 2018.
Patient problems: Impaired Healing
MAUDE report 7468129 ↗
Other KLS-Martin L.P. products
- LEVEL ONE CMF150 models · 434 reports
- LEVEL ONE36 models · 205 reports
- DISTRACTION, INTERNAL67 models · 180 reports
- LEVEL ONE THORACIC, STERILE30 models · 166 reports
- LEVEL ONE THORACIC20 models · 78 reports
- IPS29 models · 69 reports
- LEVEL ONE NEURO27 models · 63 reports
- DISTRACTION, INTERNAL, STERILE22 models · 47 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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