RapidSorb 852.421.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587064352), received between Dec 13, 2019 and May 27, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K030069, K062789); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 27, 2025Naturally Worn; Migration; Naturally Worn; Migration

  IT WAS REPORTED THAT ONE OF THE RESORBABLE PLATES THAT WAS IMPLANTED DURING PATIENT'S CRANIOSYNOSTOSIS REPAIR IN (B)(6) 2024 WAS PALPABLE AND VISIBLE. THE NORMAL RESORPTION/DEGRADATION TIME OF THESE PLATES WAS APPROXIMATELY 12 MONTHS. THERE HAS NOT BEEN A REMOVAL SURGERY. THERE WERE NO OTHER CLINICAL FINDINGS.

  Patient problems: Insufficient Information

  MAUDE report 22087167 ↗
• InjuryFeb 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD A CRANIAL VAULT RECONSTRUCTION SURGERY. THE PATIENT WAS TAKEN BACK TO THE ON (B)(6) 2020 FOR REMOVAL OF THE AFFECTED PLATE. AFTER THE INCISION/ EXPOSURE OF THE AFFECTED AREA IT WAS DETERMINED THAT THE PLATE THAT BUCKLED WAS NOT THE 1.5MM RESORBABLE STRUT PLATE 2 X 36 HOLES (851.436.01S), BUT INSTEAD A 2.0MM RESORBABLE STRUT PLATE 2 X 18 HOLES (852.421.01S) WITH 2.0MM RESORBABLE CORTEX SCREWS (8 EA) (806.004.10S). THE GAP IN THE BONE THAT PLATE SPANNED WAS 15MM. THE SURGEON USED A PERIOSTEAL ELEVATOR TO PRY THE PLATE OFF OF THE BONE FOR REMOVAL AND AS A RESULT HE BROKE THE PLATE IN HALF AND SHEARED THE SCREWS. UPON REMOVAL OF THE AFFECTED PLATE/ SCREWS THE WOUND WAS DEBRIDED, IRRIGATED, AND CLOSED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE 2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9744167 ↗
• InjuryFeb 21, 2020Migration; Migration

  IT WAS REPORTED THAT ON FEBRUARY 1, 2020, THE PATIENT HAD CRANIAL VAULT RECONSTRUCTION SURGERY ON (B)(6) 2020, IT WAS FURTHER REPORTED AFTER INCISION/EXPOSURE OF THE AFFECTED AREA IT WAS DETERMINED THAT THE PLATE THAT BUCKLED WAS NOT THE 1.5MM RESORBABLE STRUT PLATE 2X36 HOLES, BUT INSTEAD A 2.0MM RESORBABLE STRUT PLATE 2X18 HOLES WITH 2.0MM RESORBABLE CORTEX SCREWS EIGHT (8) EACH. SPECIFIC LOT NUMBERS FOR THE PLATE OR SCREWS CANNOT BE IDENTIFIED SINCE THERE WAS MORE THAN ONE LOT NUMBER USED FOR EACH. THE GAP IN THE BONE THAT PLATE SPANNED WAS 15MM. UPON REMOVAL OF THE AFFECTED PLATE/SCREWS, THE WOUND WAS DEBRIDED, IRRIGATED, AND CLOSED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THIS IS REPORT 01 OF 03 OF (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9741874 ↗
• InjuryDec 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD FRONTAL ORBITAL ADVANCEMENT SURGERY ON (B)(6) 2019, AND THE SURGEON USED FOUR (4) EACH OF THE 2.0MM RAPID RESORBABLE STRUT PLATE AND A TOTAL OF NINE (9) PACKAGES OF 2.0MM RAPID RESORBABLE CORTEX SCREW. ON NOVEMBER SEVENTEEN TO EIGHTEEN THE PLATES ON THE LATERAL ASPECTS OF THE ADVANCEMENT BUCKLED, THEY DID NOT BREAK. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2019, FOR REMOVAL OF THE LATERAL PLATES/SCREWS AND RE-PLATING. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOMES WERE GOOD. CONCOMITANT DEVICES REPORTED: 2.0MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE (PART# 806.004.04S, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9467652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030069, K062789. One submission often covers many models, so check the product and lot details in each record.

• Z-1918-2016 · May 2, 2016 · Terminated
  1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Inte
• Z-1920-2016 · May 2, 2016 · Terminated
  1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intend
• Z-1919-2016 · May 2, 2016 · Terminated
  1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intend