TiMeshRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 225
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 15 models of TiMesh by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 225 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Feb 12, 2026 — classified as 7 injuries, 218 malfunctions.
The most frequently reported specific device problem is “Break” (216 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 TiMesh problems
Device problems
- Break216
- Fracture45
- Adverse Event Without Identified Device or Use Problem3
- Naturally Worn3
Patient problems
- No Clinical Signs, Symptoms or Conditions146
- No Known Impact Or Consequence To Patient118
- Unspecified Tissue Injury3
- Post Operative Wound Infection1
- Seroma1
- Tissue Breakdown1
- Unspecified Infection1
- Wound Dehiscence1
TiMesh models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TiMesh® 9001640Screw, fixation, bone132 reports
- TiMesh 015-042Plate, fixation, bone26 reports
- TiMesh 015-044Plate, fixation, bone25 reports
- TiMesh® 015-044PLATE, FIXATION, BONE12 reports
- TiMesh 015-246Plate, fixation, bone9 reports
- TiMesh® 015-042PLATE, FIXATION, BONE7 reports
- TiMesh 015-262-18Screw, fixation, bone5 reports
- TiMesh 016-152Plate, fixation, bone2 reports
- TiMesh® 016-152PLATE, FIXATION, BONE1 report
- TiMesh 015-018Plate, fixation, bone1 report
- TiMesh 015-237Plate, fixation, bone1 report
- TiMesh 015-262-14Screw, fixation, bone1 report
- TiMesh 016-200Plate, fixation, bone1 report
- TiMesh 8001533-6Plate, fixation, bone1 report
- TiMesh® 015-262-18Screw, fixation, bone1 report
Recent TiMesh adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A TITANIUM PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE CONNECTING PLATE BROKE DURING A CRANIOTOMY. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322724 ↗MalfunctionSep 16, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT THERE WAS BREAKAGE/FRACTURE OF THE PLATE OCCURRED DURING THE DISINFECTION PROCESS. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063843 ↗InjuryMar 6, 2025Break; Fracture; Break; Fracture
(B)(6) 2025 ARED, CF (FOR, HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE PATIENT WAS LEFT WITH A RIGHT SKULL DEFECT AFTER UNDERGOING "CRANIOTOMY AND HEMATOMA REMOVAL" UNDER GENERAL ANESTHESIA ON (B)(6) 2022, DUE TO TRAUMA MORE THAN 2 YEARS AGO, AND WAS ADMITTED TO HOSPITAL ON (B)(6) 2024, FOR "OPEN CRANIOCEREBRAL INJURY POSTOPERATIVE SKULL DEFECT". AFTER COMPLETING RELEVANT EXAMINATIONS, THE PATIENT UNDERWENT SKULL DEFECT REPAIR ON (B)(6) 2024. AFTER THE OPERATION, THEY RECEIVED SYMPTOMATIC TREATMENT WITH FLUID INFUSION. REEXAMINATION SHOWED A SMALL AMOUNT OF FLUID ACCUMULATION UNDER THE FLAP. THE PATIENT WAS TRANSFERRED TO THE REFERRAL HOSPITAL ON (B)(6) 2024, FOR CONTINUED REHABILITATION TREATMENT. ON (B)(6) 2025, THE TITANIUM STRIP WAS FOUND TO BE FRACTURED. AFTER EVALUATING THE CONDITION, A SECOND SURGERY WILL BE PERFORMED IN THE NEAR FUTURE.
Patient problems: Seroma
MAUDE report 21538722 ↗MalfunctionDec 27, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT DURING INSPECTION UPON THE ARRIVAL OF THE PURCHASED GOOD, IT WAS FOUND THAT THE PRODUCT WAS KINKED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21025691 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A CRANIAL MESH FOR A SKULL DEFECT REPAIR. IT WAS REPORTED THAT ONE YEAR AGO, THE PATIENT'S LEFT FOREHEAD SURGICAL INCISION SHOWED INCISION DEHISCENCE, THE TITANIUM PLATE WAS SLIGHTLY EXPOSED, AND THE SKIN NUTRITION WAS POOR. AFTER CONTACTING THE HOSPITAL, SURGERY WAS RECOMMENDED TO REMOVE THE TITANIUM PLATE. AFTER CAREFUL CONSIDERATION, THE FAMILY REQUESTED CONSERVATIVE TREATMENT. AFTER TREATMENT, THE PATIENT'S CONDITION PROGRESSIVELY WORSENED AND THE EXPOSURE AREA OF THE LEFT FRONTAL TITANIUM PLATE PROGRESSIVELY EXPANDED. THE PATIENT HAD BEEN TAKING ENALAPRIL 10MG ORALLY FOR A LONG TIME, ABOUT 12 YEARS AGO. THE PATIENT UNDERWENT INTRACEREBRAL HEMATOMA REMOVAL AND DECOMPRESSIVE CRANIECTOMY, AND HAD A HISTORY OF SECONDARY EPILEPSY. RECENTLY, THE PATIENT HAD TAKEN LEVETIRACETAM TABLETS 0.25 ONCE A NIGHT. UNDER GENERAL ANESTHESIA, SKULL METAL PLATE REMOVAL, EPIDURAL ABSCESS EXCISION AND SKIN DEFECT REPAIR WERE PERFORMED. THE OPERATION WENT SMOOTHLY. AFTER THE OPERATION, ECG MONITORING, OXYGEN INHALATION, NEBULIZATION, AS WELL AS HEMOSTASIS, ANTI-INFLAMMATORY AND FLUID REPLACEMENT WERE GIVEN, SO AS TO INCREASE ENTERAL NUTRITION, AND REGULAR DRES
Patient problems: Wound Dehiscence
MAUDE report 20852311 ↗MalfunctionOct 9, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE SURGEON USED THE CRANIOMAXILLOFACIAL FIXATION SYSTEM TO INSTALL A 2-HOLE 8MM STANDARD STRAIGHT PLATE. THE FIRST SCREW WAS SCREWED IN NORMALLY. AFTER THE SECOND SCREW WAS SCREWED IN, IT WAS FOUND THAT THE CONNECTION PLATE WAS BROKEN. THE BROKEN PART WAS IMMEDIATELY REMOVED, AND THE CIRCULATING NURSE REPLACED THE CRANIOMAXILLOFACIAL FIXATION SYSTEM, WHICH THE SURGEON USED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407483 ↗MalfunctionSep 3, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT DURING THE DISINFECTION PROCESS, THE HOLE EXPANDED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20124948 ↗MalfunctionJan 29, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CRANIAL REPAIR DEVICE. IT WAS REPORTED THAT DURING THE OPERATION, THE PATIENT'S SKULL WAS FRACTURED REQUIRING THE USE OF A CRANIOFACIAL OSTEOSYNTHESIS SYSTEM. WHEN CONNECTED AND FIXED, THE REDUCTION WAS MAINTAINED, THE CRANIAL BONE PLATE BROKE DURING THE SCREW INSERTION PROCESS. THE DEVICE WAS REPLACED WITH A NEW CONNECTING PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18595124 ↗MalfunctionJan 25, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT DURING THE OPERATION, THE PATIENT'S SKULL WAS BROKEN, AND A CRANIOFACIAL OSTEOSYNTHESIS SYSTEM WAS REQUIRED. DURING THE USE OF THE SYSTEM, WHEN CONNECTED AND FIXED, AND THE REDUCTION WAS MAINTAINED, THE CRANIAL BONE PLATE BROKE DURING THE SCREW INSERTION PROCESS. THE DEVICE WAS RETURNED TO THE HOSPITAL LOGISTICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18579852 ↗MalfunctionJan 4, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18448072 ↗MalfunctionJan 4, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18447798 ↗MalfunctionJan 4, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18447434 ↗MalfunctionJan 4, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18446863 ↗MalfunctionJan 4, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18446804 ↗MalfunctionJan 4, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING CRANIAL REPAIR PRODUCTS. IT WAS REPORTED THAT WHEN USING THE HAND TOOLS TO TIGHTEN THE SCREW DURING SURGERY, DUE TO THE LACK OF SELF-TAPPING PROPERTIES OF THE SCREW, THE DOCTOR NEEDED TO USE MORE FORCE TO TIGHTEN THE SCREW CAUSING THE SNOWFLAKE PIECE, CONNECTING PIECE, AND SCREW TO DEFORM AND MAKING IT IMPOSSIBLE TO CONTINUE USING IT. IT WAS NOTED THAT THE HOSPITAL SUPPLY ROOM COLLECTED DAMAGED PRODUCTS FROM VARIOUS MANUFACTURERS ON A DAILY BASIS AND PROVIDED THEM TO THE DISTRIBUTOR AT ONE TIME DURING THE INVENTORY PERIOD AT THE END OF THE YEAR. IT WAS ASKED FOR THE DOCTORS TO USE MEDTRONIC PRODUCTS OF THE SAME MODEL INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18446763 ↗
Other Medtronic Ps Medical, Inc. products
All Medtronic Ps Medical, Inc. 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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