AESCULAP FF904SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04038653364312), received between Feb 24, 2021 and Jan 9, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP INC. THAT A CASPAR DISTRACTION PIN 14MM. (PART # FF904SB) WAS USED DURING REMOVAL OF DISC/ARTHROPLASTY AND ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) C4-5 SURGERY. ACCORDING TO THE COMPLAINANT THE PIN BROKE AND THE PIECE COULD NOT BE EXPLANTED. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 21114457 ↗
• InjuryJan 10, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP INC. THAT A CASPAR DISTRACTION PIN 14MM (ITEM # FF904SB) WAS USED DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTRACTION PIN BROKE OFF INTO THE CERVICAL VERTEBRAE AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER AESCULAP DISTRACTION PIN. THE TOP TIP OF THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A FRAGMENT REMAINED IN SITU; THE TOP TIP OF PIN WAS AVAILABLE FOR RETURN. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132017 ↗
• MalfunctionJan 9, 2023Material Fragmentation; Material Fragmentation

  UPDATE: THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125125 ↗
• InjuryFeb 11, 2022Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device

  IT WAS REPORTED TO AESCULAP AG THAT A CASPAR DISTRACTION PIN 14MM (PART # FF904SB) WAS USED DURING AN ANTERIOR CERVICAL SPINAL PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, UPON OPENING THE PACKET, FOREIGN MATTER WAS NOTED TO BE ADHERED TO THE PIN. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE WAS A SURGICAL DELAY DURING WHICH THE STERILE AREA WAS REESTABLISHED. A 12MM SCREW WAS USED INSTEAD. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518573 ↗
• InjurySep 9, 2021Material Fragmentation; Material Fragmentation

  NO CHANGES REQUIRED.

  Patient problems: Failure of Implant

  MAUDE report 12446829 ↗
• MalfunctionSep 8, 2021Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FF904SB - CASPAR DISTRACTION PIN 14MM VIA INFORMATION RECEIVED FROM MW 0504140000-2021-8002. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PIN BROKE DURING SURGERY AND REMAINED IN SITU. DISTRACTION PIN SHEARED WHEN SURGEON ATTEMPTED TO REMOVE IT FROM C3. (IT SHEARED WITHOUT ANY ABOVE AVERAGE AMOUNT OF FORCE). A PORTION OF THE PIN WAS FULLY EMBEDDED IN BONE WITHOUT ANY POTENTIAL TO CAUSE HARM. THE PIECE BROKE OFF IN THE BONE. IT WOULD NOT HAVE BEEN SAFE TO REMOVE IT. NO SURGERY DELAY. A FRAGMENT REAMINED IN SITU. ADDITIONAL DETAILS WERE NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442381 ↗
• InjuryJun 23, 2021Break; Break

  NO UPDATES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12050806 ↗
• MalfunctionJun 21, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FF904SB - CASPAR DISTRACTION PIN 14MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TIP OF THE DEVICE BROKE DURING SURGERY. WHILE TRYING TO REMOVE THE PIN, THE TIP BROKE OFF INTO THE ANTERIOR VERTREBAL BODY. THE PIECE WAS LEFT INSITU AS THE SURGEON STATED THAT TRYING TO REMOVE IT WOULD CAUSE MORE HARM TO PATIENT. THERE WAS NO PATIENT HARM BUT A SURGICAL DELAY OF 30 MINUTES OCCURRED. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033772 ↗
• InjuryMar 25, 2021Break; Break

  KW 05-06-2021. IT WAS REPORTED AESCULAP AG THAT A CASPAR DISTRACTION PIN 14MM (PART # FF904SB) WAS USED DURING AN UNKNOWN PROCCEDURE PERFORMED ON (B)(6), 2021. ACCORDING TO THE COMPLAINANT, THE SCREW BROKE DURING SURGERY. RUPTURE WITH INTRAOSSEOUS SEQUESTRATION OF A CASPAR DISTRACTION SCREW DURING THE INTERVENTION OF A CURE FOR C6-C7 PSEUDO-ARTHROSIS AND INSTALLATION OF OSD PLATE. CONSEQUENCE: PERSISTENCE OF MATERIAL AT LEVEL C6. A FRAGMENT OF THE BROKEN DEVICE REAMINED IN SITU. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11571959 ↗
• InjuryFeb 24, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FF904SB-CASPAR DISTRACTION PIN 14MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CASPAR SCREW BROKE DURING SURGERY ON (B)(6). THE BROKEN PART REMAINED IN THE VERTEBRA, BY MEDICAL CHOICE. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11373042 ↗