PRO 425942SRecalls & reported problems
Stryker GmbH · Suprapectineal Flex Plate 12-hole, left · Class 2 · Implant
All models of PRO (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327546606), received between May 15, 2025 and May 15, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Arthritis1
- Bone Fracture(s)1
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A STRYKER COLLABORATIVE STUDY (SCS) NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO PELVIS NEXT GENERATION IMPLANTS. RETROSPECTIVE ANALYSIS WAS CONDUCTED USING THE CLINIC DOCUMENTS AND RADIOGRAPHIC IMAGES OF CASES AT (B)(6) FROM JANUARY 2024- DECEMBER 2024 DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: PATIENT 9 DEVELOPED OSTEOLYSIS, ARTHRITIS, AND BONE FRACTURES ASSOCIATED WITH POST-TRAUMATIC OSTEOARTHRITIS AT 209 DAYS POST-OPERATIVELY. THIS EVENT WAS CATEGORIZED AS MODERATE AND IS STILL ONGOING WITHOUT NECESSITATING REVISION SURGERY. THE RELATIONSHIP TO BOTH THE DEVICE AND PROCEDURE WAS CONSIDERED POSSIBLY RELATED.
Patient problems: Arthritis; Bone Fracture(s); Osteolysis
MAUDE report 22026305 ↗
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page