Petite Stepped MPJ VLC Gridlock Plate Right 300-52-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812926025353), received between Apr 28, 2017 and Jul 22, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K130964); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2020Fracture; Fracture

  ON (B)(6) 2020, A TRILLIANT SURGICAL SALES REPRESENTATIVE REPORTED THE REMOVAL OF A 300-52-004 (PETITE MPJ VLC GRIDLOCK PLATE RIGHT; LOT TSL006823) DUE TO THE PATIENT REPORTING PAIN AND A PALPABLE BUMP THAT COULD BE SEEN OVER THE SURGICAL SITE. AFTER FURTHER INVESTIGATION INTO WHAT WAS CAUSING THE PAIN, IT WAS DISCOVERED THAT THE 300-52-004 HAD BROKEN TOWARDS THE PROXIMAL SIDE OF THE PLATE. THE 300-52-004 WAS ORIGINALLY IMPLANTED BY DOCTOR 1 ON (B)(6) 2020 AT FACILITY 1. THE PATIENT REPORTED PAIN AND DISCOVERY OF THE BROKEN PLATE WAS REPORTED TO BE (B)(6) 2020. PATIENT INFORMATION IS UNKNOWN AT THIS TIME, THERE WAS NO REPORTED NON-COMPLIANCE. THE REMOVAL PROCEDURE OCCURRED ON (B)(6) 2020 AT FACILITY 1 BY DOCTOR 1. THE SALES REPRESENTATIVE REPORTED THE REMOVAL WENT WELL, BUT UPON REMOVING THE BROKEN PLATE, A BLUE-ISH/BLACK PIGMENT WAS LEFT BEHIND ON THE TISSUE. THIS IS SUSPECTED TO BE METALLOSIS, BUT IS BEING CONFIRMED VIA PATHOLOGY TESTING. THE SITE WAS SCRAPED CLEAR OF THE DISCOLORATION. DOCTOR 1 REPORTED THERE WAS PARTIAL FUSION UPON REMOVING THE PLATE, BUT IN ORDER TO ENSURE THE JOINT WAS STABLE, HE IMPLANTED A SECONDARY INTERFRAGMENTARY SCREW DISTAL TO PROXIMAL TO CROSS WITH AN

  Patient problems: Impaired Healing; Pain

  MAUDE report 10307919 ↗
• MalfunctionMar 23, 2018Break

  THE SURGEON IMPLANTED A 300-52-004 PETITE MPJ PLATE ON (B)(6) 2017. THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON UTILIZED X-RAYS TO DISCOVER THAT THE PLATE WAS BROKEN AND NO FUSION HAD OCCURRED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. ACCORDING TO TRILLIANT'S SALES REPRESENTATIVE AT THE CASE, THE SURGEON REMOVED THE LAG SCREW AND THE ENTIRE 300-52-004 PETITE PLATE AND ASSOCIATED SCREWS LIFTED OFF THE SURGICAL SITE WITHOUT THE USE OF THE 310-30-003 GRIDLOCK DRIVER. THE SURGEON UTILIZED ANOTHER COMPANIES HARDWARE IN THE REVISION SURGERY. THE 300-52-004 PETITE GRIDLOCK PLATE AND ASSOCIATED SCREWS HAVE BEEN RETAINED BY THE FACILITY AS THE SURGEON WANTED TO REVIEW THE HARDWARE WITH THE PATIENT. TRILLIANT HAS REQUESTED TO RECEIVE THE PARTS BACK AFTER THE SURGEON HAS FINISHED REVIEWING THE HARDWARE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7367929 ↗
• InjuryFeb 3, 2018Break

  PATIENT CAME INTO THE SURGEON'S OFFICE EXPERIENCING PAIN AND IRRITATION AROUND THE SURGICAL SITE. AFTER THE SURGEON X-RAYED THE SITE, IT WAS VISIBLE THAT THE (B)(4) PETITE MPJ PLATE AND THE INTERFRAG SCREW (B)(4) WERE BROKEN IN THE PATIENT. THE SURGEON REMOVED THE (B)(4) PLATE AND ASSOCIATED SCREWS. SINCE A FUSION HAD NOT OCCURRED, THE SURGEON UTILIZED A SILASTIC IMPLANT ON THE MPJ. TRILLIANT'S SALES REPRESENTATIVE AT THE REMOVAL CASE, NOTED THAT THE SURGEON STATED THE PROXIMAL PHALANX WAS A BIT "SOFT" WHEN HE WAS INSERTING THE SILASTIC IMPLANT. TRILLIANT'S SALES REPRESENTATIVE STATED THAT THE (B)(4) PLATE AND SCREWS WERE INSERTED APPROXIMATELY EIGHT MONTHS AGO, ALTHOUGH HE IS CHECKING WITH THE FACILITY TO CONFIRM THE DATE OF IMPLANTATION. THE (B)(4) PLATE AND SCREWS WILL BE RETURNED TO TRILLIANT SURGICAL FOR REVIEW.

  Patient problems: Pain

  MAUDE report 7239799 ↗
• MalfunctionApr 28, 2017Break

  A PATIENT (A (B)(6) OLD MALE) CAME INTO THE OFFICE DURING A FOLLOW UP APPOINTMENT AFTER HAVING AN MPJ FUSION ON (B)(6) 2016. WHEN X-RAYS WERE TAKEN OF THE SURGICAL SITE DURING THE FOLLOW UP, IT WAS NOTICED THAT THE RIGHT PETITE MPJ PLATE HAD BROKEN IN THE PATIENT. THE PATIENT SAID HE HAD EXPERIENCED SOME PAIN ONCE IT WAS NOTED THAT THE PLATE WAS BROKEN. ACCORDING TO THE DOCTOR, THE PATIENT WAS HEALING FINE INITIALLY AND MIGHT NOT HAVE BEEN FULLY COMPLIANT. A FUSION WAS NOT COMPLETE AND THERE WAS SOME DEVIATION. THE DOCTOR TALKED WITH THE PATIENT REGARDING THE SITUATION AND THE PATIENT DOES NOT WANT SURGERY AT THIS TIME. THE DOCTOR DECIDED THE DEVIATION WAS NOT SEVERE ENOUGH TO MAKE A SURGERY MANDATORY AT THIS TIME. THE DOCTOR WILL CONTINUE TO MONITOR THE PATIENT AND THE PLATE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6529382 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130964. One submission often covers many models, so check the product and lot details in each record.

• Z-1609-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant