PANGEARecalls & reported problems across all models
Stryker GmbH · 53 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 84
- Deaths reported
- 2
- Injuries reported
- 63
- Recalls
- 0
We found 53 models of PANGEA by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2024 and Sep 21, 2026 — classified as 2 deaths, 63 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Fracture” (24 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 PANGEA problems
Device problems
- Fracture24
- Adverse Event Without Identified Device or Use Problem23
- Migration17
- Break12
- Device Difficult to Setup or Prepare8
- Device Dislodged or Dislocated6
- Loosening of Implant Not Related to Bone-Ingrowth5
- Malposition of Device4
Patient problems
- Insufficient Information32
- Post Operative Wound Infection20
- Foreign Body In Patient16
- No Clinical Signs, Symptoms or Conditions13
- Failure of Implant3
- Perforation3
- Pain2
- Bone Fracture(s)1
PANGEA models
53 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PANGEA 542020INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT8 reports
- PANGEA 662202SScrew, fixation, bone6 reports
- PANGEA 542021INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT6 reports
- PANGEA 542110INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT4 reports
- PANGEA 662375Screw, fixation, bone3 reports
- PANGEA 662238Screw, fixation, bone2 reports
- PANGEA 662246Plate, fixation, bone2 reports
- PANGEA 662334Plate, fixation, bone2 reports
- PANGEA 662346Screw, fixation, bone2 reports
- PANGEA 662350Plate, fixation, bone2 reports
- PANGEA 662338Screw, fixation, bone2 reports
- PANGEA 540530Screw, fixation, bone2 reports
- PANGEA 542001INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- PANGEA 542021SINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
- PANGEA 662234Screw, fixation, bone1 report
- PANGEA 662236Plate, fixation, bone1 report
- PANGEA 627842Plate, fixation, bone1 report
- PANGEA 662240Screw, fixation, bone1 report
- PANGEA 662242Plate, fixation, bone1 report
- PANGEA 627843Plate, fixation, bone1 report
- PANGEA 662385Plate, fixation, bone1 death1 report
- PANGEA 662370Screw, fixation, bone1 report
- PANGEA 662250Screw, fixation, bone1 report
- PANGEA 662275Plate, fixation, bone1 report
- PANGEA 627849Screw, fixation, bone1 report
- PANGEA 627853Plate, fixation, bone1 report
- PANGEA 662330Plate, fixation, bone1 report
- PANGEA 662328Plate, fixation, bone1 report
- PANGEA 662360Plate, fixation, bone1 report
- PANGEA 662355Plate, fixation, bone1 report
- PANGEA 627811Plate, fixation, bone1 report
- PANGEA 662340Plate, fixation, bone1 report
- PANGEA 541438Screw, fixation, bone1 report
- PANGEA 541565Screw, fixation, bone1 report
- PANGEA 541560Screw, fixation, bone1 report
- PANGEA 541528Screw, fixation, bone1 report
- PANGEA 541542Screw, fixation, bone1 report
- PANGEA 541526Screw, fixation, bone1 report
- PANGEA 541037Screw, fixation, bone1 report
- PANGEA 540083SScrew, fixation, bone1 report
- PANGEA 540184SPlate, fixation, bone1 report
- PANGEA 540182Screw, fixation, bone1 death1 report
- PANGEA 540268SScrew, fixation, bone1 report
- PANGEA 540204Screw, fixation, bone1 report
- PANGEA 540435SScrew, fixation, bone1 report
- PANGEA 540405Plate, fixation, bone1 report
- PANGEA 540180Plate, fixation, bone1 report
- PANGEA 542034Orthopedic manual surgical instrument1 report
- PANGEA 540804SScrew, fixation, bone1 report
- PANGEA 540838SPlate, fixation, bone1 report
- PANGEA 540834SPlate, fixation, bone1 report
- PANGEA 542130INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
- PANGEA 662218Screw, fixation, bone1 report
Recent PANGEA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848692 ↗InjurySep 16, 2026Fracture
It was reported that during a routine left total hip makoplasty the surgeon had finished putting the implants in the patient. He then used a drill bit to pass suture for the initial portion of closure of the hip capsule. Whilst doing this the fluted portion of the drill bit broke off while being used in the patient. An initial search was done for the bit with no results, so x-ray was notified and came to the room. Two shots were taken to assess where the drill bit was located. The surgeon read the x-rays and determined that the broken portion of the drill bit was in the patients left femur. He decided to leave the drill bit in situ as the costs of retrieving it would be greater that the benefits of it being removed. The patients hip was then closed and the surgery was concluded.
Patient problems: Foreign Body In Patient
MAUDE report 50792135 ↗InjurySep 10, 2026Fracture
As reported: "A drill bit for the Pangea small frag system broke today during use.The tip of the drill bit was reported and broke off in the patient's bone. Was not removed from patient."
Patient problems: Foreign Body In Patient
MAUDE report 50715194 ↗MalfunctionAug 28, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506042 ↗InjuryAug 28, 2026Fracture
As reported: "During a Pangea PH procedure, drilling was performed through the posterior screw hole in the second row from the proximal side. After screw insertion, fluoroscopic/X-ray confirmation revealed that the tip of the drill bit had fractured and remained within the bone.The surgeon determined that removal of the fractured drill bit tip was not feasible and therefore completed the procedure with the fragment left in situ."
Patient problems: Foreign Body In Patient
MAUDE report 50500183 ↗MalfunctionAug 26, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459567 ↗InjuryAug 25, 2026Loosening of Implant Not Related to Bone-Ingrowth
As reported: "The patient underwent open reduction and internal fixation for a humeral fracture on (b)(6) 2025. On (b)(6) 2026, refracture associated with loss of fixation of the humeral plate was identified. Revision surgery was performed on (b)(6) 2026, and the fixation was converted to an intramedullary nail. Two X-ray images regarding reported issue were provided from the facility."
Patient problems: Bone Fracture(s)
MAUDE report 50431520 ↗MalfunctionAug 5, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147215 ↗InjuryJul 28, 2026Fracture
As reported: "The surgeon was drilling using 542110 through the targeter. The drill bit broke inside of the tibial canal attempting to drill through the far cortex.The tip of the drill bit that broke off stayed inside the tibia. The surgeon decided it would cause more harm than good to try and fish the broken piece out of the tibia."
Patient problems: Foreign Body In Patient
MAUDE report 50061368 ↗MalfunctionJul 16, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846109 ↗MalfunctionJul 2, 2026Fracture
AS REPORTED: "THE SURGEON WAS DRILLING USING 542110 THROUGH THE TARGETER. THE DRILL BIT BROKE INSIDE OF THE TIBIAL CANAL ATTEMPTING TO DRILL THROUGH THE FAR CORTEX."
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 25690343 ↗InjuryJun 30, 2026Fracture
AS REPORTED: "DURING DRILLING, THE TIP OF THE DRILL BROKE OFF DUE TO INTERFERENCE WITH AN ALREADY INSERTED SCREW, LEAVING ABOUT 2MM INSIDE THE BODY. IT COULD NOT BE REMOVED, SO THE WOUND WAS CLOSED IN THAT STATE."
Patient problems: Foreign Body In Patient
MAUDE report 25668249 ↗InjuryMay 29, 2026Fracture
THE DRILL BIT BROKE DURING A PANGEA TIBIAL SURGERY. IT BROKE WHEN IT CAME INTO CONTACT WITH THE PLATE ON THE OPPOSITE SIDE DURING A DOUBLE-PLATE PROCEDURE. THE SURGERY WAS COMPLETED WHILE THE TIP OF THE BROKEN DRILL BIT REMAINED INSIDE THE PATIENT'S BODY.
Patient problems: Foreign Body In Patient
MAUDE report 25332368 ↗DeathMay 22, 2026Device Dislodged or Dislocated
IT WAS REPORTED: "PLATE LOCKING SCREWS BECAME PROMINENT AFTER THE LOCKING MECHANISM UNCOUPLED RESULTING IN A LACK OF STABILITY AND HWR SURGERY. A SINGLE DISTAL LATERAL LOCKING 5.0 SCREW WAS VISIBLE UNDERNEATH THE PLATE SURFACE CONFIRMING SCREW TEAR THRU THE LOCKING MECHANISM OF THE PLATE. UNUSUAL PERFORMANCE OF THE LOCKING PLATE WAS QUESTIONED BY THE SURGEON AND PATIENT WAS THEN STAGED WITH A STATIC SPACER WITH ANTIBIOTICS ON (B)(6) 2026 AND THEN A DFR SCHEDULED A FEW DAYS LATER. HOWEVER, BEFORE THE PATIENT'S DFR THEY PASSED AWAY FROM POST-SURGICAL COMPLICATIONS RELATED TO GENERAL HEALTH AND OPTIMIZATION."
Patient problems: Insufficient Information
MAUDE report 25255962 ↗DeathMay 22, 2026Detachment of Device or Device Component
IT WAS REPORTED: "PLATE LOCKING SCREWS BECAME PROMINENT AFTER THE LOCKING MECHANISM UNCOUPLED RESULTING IN A LACK OF STABILITY AND HWR SURGERY. A SINGLE DISTAL LATERAL LOCKING 5.0 SCREW WAS VISIBLE UNDERNEATH THE PLATE SURFACE CONFIRMING SCREW TEAR THRU THE LOCKING MECHANISM OF THE PLATE. UNUSUAL PERFORMANCE OF THE LOCKING PLATE WAS QUESTIONED BY THE SURGEON AND PATIENT WAS THEN STAGED WITH A STATIC SPACER WITH ANTIBIOTICS ON (B)(6) 2026 AND THEN A DFR SCHEDULED A FEW DAYS LATER. HOWEVER, BEFORE THE PATIENT'S DFR THEY PASSED AWAY FROM POST-SURGICAL COMPLICATIONS RELATED TO GENERAL HEALTH AND OPTIMIZATION."
Patient problems: Insufficient Information
MAUDE report 25255960 ↗
Other Stryker GmbH products
All Stryker GmbH 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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