Baby Gorilla/Gorilla Plating SystemRecalls & reported problems across all models
Paragon 28, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Baby Gorilla/Gorilla Plating System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 10 models of Baby Gorilla/Gorilla Plating System by Paragon 28, Inc. in the FDA's device registry (GUDID). Together they are named in 18 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2020 and Sep 14, 2026 — classified as 3 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Baby Gorilla/Gorilla Plating System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 18, 2022Open, Classified
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Z-1458-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Baby Gorilla/Gorilla Plating System problems
Device problems
- Fracture15
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Foreign Body In Patient1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Baby Gorilla/Gorilla Plating System models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1 recall0 reports
- Baby Gorilla/Gorilla Plating System P99-191-TR10Screw, fixation, bone9 reports
- Baby Gorilla/Gorilla Plating System P99-191-LR10Screw, fixation, bone2 reports
- Baby Gorilla/Gorilla Plating System P50-053-2036Screw, fixation, bone1 report
- Baby Gorilla/Gorilla Plating System P50-053-2528Screw, fixation, bone1 report
- Baby Gorilla/Gorilla Plating System P50-153-2522Screw, fixation, bone1 report
- Baby Gorilla/Gorilla Plating System P99-150-0014GAUGE, DEPTH1 report
- Baby Gorilla®/Gorilla® Plating System P53-402-L102Plate, fixation, bone1 report
- Baby Gorilla®/Gorilla® Plating System P53-402-R101Plate, fixation, bone1 report
- Baby Gorilla®/Gorilla® Plating System P99-191-AF10Screw, fixation, bone1 report
Recent Baby Gorilla/Gorilla Plating System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Fracture
It was reported that a recon screwdriver tip broke during an (b)(6) ankle procedure. During the procedure, no fragments or components fell into the patient, and the surgery was completed using a secondary screwdriver available as backup. There were no consequences or impact to the patient. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752407 ↗MalfunctionAug 26, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50458732 ↗InjuryJul 27, 2026Fracture
It was reported that a broken Non-Locking Screw(2.5mm) identified during a recent procedure. It caused no injury and the procedure was delayed by less than 30 minutes. The shaft remains inside the patient¿s body, while only the head was retrieved. Attempts have been made and no further information has been provided.
Patient problems: Foreign Body In Patient
MAUDE report 50045732 ↗MalfunctionJul 2, 2026Fracture
IT WAS REPORTED THAT DURING SURGERY THE DRIVER TIP BROKE WHILE TIGHTENING A SCREW. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT, THERE WAS NO DELAY IN THE PROCEDURE, AND THE SURGERY WAS COMPLETED USING A SECOND DRIVER FROM THE SET. THE PATIENT HAD NO CONSEQUENCES OR IMPACT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25692857 ↗MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT A SCREW DRIVER BROKE DURING A PROCEDURE. ALL DEBRIS WAS REMOVED FROM THE PATIENT. THE EVENT CAUSED A DELAY OF 5-10 MINUTES WITH NO CONSEQUENCES OR IMPACT TO THE PATIENT. A DIFFERENT DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE WITH NO ADDITIONAL SURGICAL COMPLICATIONS NOTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337579 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT THREADS ON A DRIVER TIP WERE FOUND TO BE CHIPPED OFF DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ONE EXPERIENCED ANY CLINICAL SIGNS/SYMPTOMS AS A RESULT OF THE DAMAGED DRIVER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25204285 ↗MalfunctionApr 29, 2026Fracture
IT WAS REPORTED THAT DURING AN ANKLE ORIF, THE SCREWDRIVER TIP BROKE WHILE THE SURGEON WAS TIGHTENING A SCREW. THE DEBRIS WAS REMOVED FROM THE PATIENT, AND A DIFFERENT INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ADDITIONAL INTERRUPTIONS. THE PATIENT HAD NO KNOWN IMPACT OR CONSEQUENCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035466 ↗MalfunctionApr 29, 2026Fracture
IT WAS REPORTED THAT DURING A PRIMARY METATARSOPHALANGEAL (MTP) ARTHRODESIS, A SCREWDRIVER TIP FRACTURED DURING THE FINAL TIGHTENING OF A LOCKING SCREW. AS THE FINAL STEP OF THE PROCEDURE, WHEN TIGHTENING THE LAST SCREW IN THE PLATE, THE DRIVER TIP BROKE. THE SCREWDRIVER WAS REPLACED, AND DURING FINAL TIGHTENING OF THE SAME SCREW, THE REPLACEMENT DRIVER TIP ALSO FRACTURED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25033933 ↗MalfunctionApr 29, 2026Fracture
IT WAS REPORTED THAT DURING A PRIMARY METATARSOPHALANGEAL (MTP) ARTHRODESIS, A SCREWDRIVER TIP FRACTURED DURING THE FINAL TIGHTENING OF A LOCKING SCREW. AS THE FINAL STEP OF THE PROCEDURE, WHEN TIGHTENING THE LAST SCREW IN THE PLATE, THE DRIVER TIP BROKE. THE SCREWDRIVER WAS REPLACED, AND DURING FINAL TIGHTENING OF THE SAME SCREW, THE REPLACEMENT DRIVER TIP ALSO FRACTURED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25033920 ↗MalfunctionApr 28, 2026Fracture
IT WAS REPORTED THAT THE SCREWDRIVER TIP FRACTURED. THE CORRECT SURGICAL TECHNIQUE WAS USED, AND AN ALTERNATE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS, SURGICAL INTERVENTIONS, OR FOREIGN BODIES RESULTED FROM THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016574 ↗MalfunctionApr 17, 2026Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, AN HX10 SCREWDRIVER BROKE WHILE INSERTING A SCREW INTO AN FTMTJ PLATE. SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. THE PATIENT'S BONE WAS NOT HARD, AND THE APPROPRIATE DRILL WAS USED. THE BROKEN FRAGMENT WAS COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE INSTRUMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912011 ↗MalfunctionApr 13, 2026Fracture
IT WAS REPORTED THE PLATES REMOVED FROM THE PATIENT ON A LATERAL TTC PLATE IMPLANTED ON THE PATIENT FOR DIABETIC FOOT RECONSTRUCTION 6 WEEKS POST-OPERATION DUE TO FATIGUE AT THE SCREW WALL ON THE POSTERIOR SECTION OF THE PLATE. THIS CONTINUED TO PROGRESS UNTIL THE PLATE SNAPPED ON THE INTERFACE BETWEEN THE TIBIA SECTION OF THE PLATE AND THE TALUS INTERFACE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860983 ↗MalfunctionMar 18, 2026Fracture
IT WAS REPORTED THAT DURING FIXATION OF A FIBULA PLATE, A SCREWDRIVER BROKE WHILE INSERTING A SCREW. THE BROKEN PORTION WAS REMOVED INTRA-OPERATIVELY AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO CONSEQUENCES OR IMPACT TO THE PATIENT. DELAY OF SURGERY WAS LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627353 ↗MalfunctionMar 2, 2026Fracture
IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF DURING THE CASE. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE CASE WITH A SURGERY DELAY OF LESS THAN 30 MINUTES. ALL DEBRIS WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24491608 ↗MalfunctionJan 26, 2026Fracture
IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF DURING THE CASE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24182466 ↗
Other Paragon 28, Inc. products
All Paragon 28, 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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