RapidSorb 805.603.10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20887587061631), received between Jul 2, 2019 and Jul 3, 2019 — classified as 4 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Skin Irritation

  MAUDE report 8758062 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Skin Irritation

  MAUDE report 8757712 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A HARDWARE REMOVAL OF RAPID RESORBABLE STRUT PLATE WAS PERFORMED DUE TO INFECTION. THERE WAS AN UNKNOWN ALLEGATION AGAINST THE BATTERY PACK-STERILE FOR BATTERY POWERED DRIVER. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH FEVER AND INFECTION AT THE SURGICAL SITE. THE PARENTS ADMITTED ALLOWING THEIR DOG TO LICK THE WOUND SITE ON BABIES HEAD THAT PROBABLY CAUSED THE INFECTION. INITIALLY, THE PATIENT HAD A SAGITTAL SYNOSTOSIS PROCEDURE ON (B)(6) 2017. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8755714 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JULY 30, 2017, A HARDWARE REMOVAL OF RAPID RESORBABLE STRUT PLATE WAS PERFORMED DUE TO INFECTION. THERE WAS AN UNKNOWN ALLEGATION AGAINST THE BATTERY PACK-STERILE FOR BATTERY POWERED DRIVER. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH FEVER AND INFECTION AT THE SURGICAL SITE. THE PARENTS ADMITTED ALLOWING THEIR DOG TO LICK THE WOUND SITE ON BABIES HEAD THAT PROBABLY CAUSED THE INFECTION. INITIALLY, THE PATIENT HAD A SAGITTAL SYNOSTOSIS PROCEDURE ON (B)(6) 2017. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8755704 ↗

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-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-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