IPSRecalls & reported problems across all models
KLS-Martin L.P. · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls
- 0
We found 29 models of IPS by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Jun 24, 2026 — classified as 68 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. 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 IPS problems
Device problems
- Adverse Event Without Identified Device or Use Problem26
- Break18
- Fracture11
- Device Issue2
- Failure to Osseointegrate2
- Installation-Related Problem2
- Loss of Osseointegration2
- Device Operates Differently Than Expected1
Patient problems
- Impaired Healing19
- Insufficient Information15
- Unspecified Infection9
- No Clinical Signs, Symptoms or Conditions6
- Nonunion/Delayed-union Bone Fracture6
- Inadequate Osseointegration5
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient3
IPS models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IPS 60-000-67-09-LPPLATE, BONE8 reports
- IPS 60-000-23-09PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE7 reports
- IPS 60-000-72-09-LPPLATE, BONE6 reports
- IPS 60-000-64-09PLATE, BONE4 reports
- IPS 60-000-64-09-LPPLATE, BONE4 reports
- IPS 60-650-01-04PLATE, BONE3 reports
- IPS 60-000-19-09PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE3 reports
- IPS 60-000-63-09PLATE, BONE3 reports
- IPS 60-660-01-04PLATE, BONE2 reports
- IPS 60-000-65-09PLATE, BONE2 reports
- IPS 60-000-69-09PLATE, BONE2 reports
- IPS 60-000-90-09PLATE, BONE2 reports
- IPS 60-008-85-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- IPS 60-008-87-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- IPS 60-000-65-09-LPDRIVER, WIRE, AND BONE DRILL, MANUAL2 reports
- IPS 60-000-69-09-LPDRIVER, WIRE, AND BONE DRILL, MANUAL2 reports
- IPS 60-004-40-09-LPPLATE, BONE2 reports
- IPS 60-500-01-09POSITIONER, TOOTH, PREFORMED2 reports
- IPS 60-620-03-04METHYL METHACRYLATE FOR CRANIOPLASTY1 report
- IPS 60-000-66-09PLATE, BONE1 report
- IPS 60-000-21-09METHYL METHACRYLATE FOR CRANIOPLASTY1 report
- IPS 60-000-24-09METHYL METHACRYLATE FOR CRANIOPLASTY1 report
- IPS 60-000-35-09PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE1 report
- IPS 60-000-36-09PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE1 report
- IPS 60-000-67-09PLATE, BONE1 report
- IPS 60-000-70-09PLATE, BONE1 report
- IPS 60-000-72-09PLATE, BONE1 report
- IPS 60-008-92-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- IPS 60-000-63-09-LPPLATE, BONE1 report
Recent IPS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IPS IMPLANT WAS REMOVED FOLLOWING APPROXIMATELY TWELVE MONTHS OF IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 25610344 ↗InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IPS IMPLANT WAS REMOVED FOLLOWING APPROXIMATELY SEVEN MONTHS OF IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 25610341 ↗InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AN IPS IMPLANT WAS REMOVED FOLLOWING APPROXIMATELY ONE MONTH OF IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 25610335 ↗InjuryJun 5, 2026Difficult to Remove
IT WAS REPORTED THAT THE IPS MIDFACE DISTRACTORS DID NOT ADVANCE AS EXPECTED, RESULTING IN DIFFICULTIES DURING REMOVAL. THEY WERE REMOVED AND REPLACED WITH ALTERNATE FIXATION PRODUCTS. DISTRACTORS WERE INTACT AND UNDAMAGED UPON EXPLANT.
Patient problems: Insufficient Information
MAUDE report 25412536 ↗InjuryMay 20, 2026Fracture
IT WAS REPORTED THAT AN IPS IMPLANT WAS IDENTIFIED AS FRACTURED FOLLOWING APPROXIMATELY FIVE MONTHS OF IMPLANTATION. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 25234213 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT RT. SIDE MANDIBULAR HARDWARE WAS REMOVED FOR UNKNOWN REASONS 14 WEEKS AFTER IMPLANTATION. THERE WERE NO REPORTED ISSUES WITH THE REMOVED PRODUCT.
Patient problems: Insufficient Information
MAUDE report 25176991 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
AN IPS IMPLANT WAS REMOVED SIX MONTHS AFTER IMPLANT FOR UNKNOWN REASONS. SURGEON ADVISED NO HARDWARE ISSUES WITH PRODUCT.
Patient problems: Insufficient Information
MAUDE report 24771350 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
AN IPS IMPLANT WAS REMOVED SIX MONTHS AFTER IMPLANT FOR UNKNOWN REASONS. SURGEON ADVISED NO HARDWARE ISSUES WITH PRODUCT.
Patient problems: Insufficient Information
MAUDE report 24771339 ↗InjuryMar 5, 2026Fracture
IT WAS REPORTED THAT A PLATE WAS IDENTIFIED AS FRACTURED. IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 24524930 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IPS IMPLANTS WERE REMOVED DUE TO UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 23855152 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IPS IMPLANTS WERE REMOVED DUE TO UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 23855129 ↗InjuryDec 5, 2025Fracture; Fracture
IT WAS REPORTED THE IPS IMPLANTS HAVE BECOME FRACTURED RESULTING IN A MOBILE MAXILLA FOLLOWING APPROXIMATELY 4 MONTHS OF IMPLANTATION. THEY WERE REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23728212 ↗InjuryDec 5, 2025Fracture; Fracture
IT WAS REPORTED THE IPS IMPLANTS HAVE BECOME FRACTURED RESULTING IN A MOBILE MAXILLA FOLLOWING APPROXIMATELY 4 MONTHS OF IMPLANTATION. THEY WERE REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23728211 ↗InjuryMay 20, 2025Fracture; Fracture
IT WAS REPORTED THE IPS IMPLANT BROKE. IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054656 ↗InjuryMay 20, 2025Fracture; Fracture
IT WAS REPORTED THE IPS IMPLANT BROKE. IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054654 ↗
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
- LEVEL ONE NEURO27 models · 63 reports
- DISTRACTION, INTERNAL, STERILE22 models · 47 reports
- LEVEL ONE ORTHOANCHOR15 models · 20 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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