RapidSorb 806.004.10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20887587061839), received between Feb 21, 2020 and Feb 24, 2020 — classified as 4 injuries.

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

• 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 2X36 HOLES (851.436.01S), BUT INSTEAD A 2.0MM RESORBABLE STRUT PLATE 2X18 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 CORTEX SCREW 4MM-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9744291 ↗
• 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 1.5 MM RESORBABLE STRUT PLATE 2 X 36 HOLES (851.436.01S), BUT INSTEAD A 2.0 MM RESORBABLE STRUT PLATE 2 X 18 HOLES (852.421.01S) WITH 2.0 MM 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 2.0 MM RAPID RESORBABLE CORTEX SCREW 4 MM-STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9744205 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD CRANIAL VAULT RECONSTRUCTION SURGERY. ON JANUARY 28, 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 02 OF 03 OF (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9741878 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 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 02 OF 03 OF (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9741877 ↗

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-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
• 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