SKYLINE 286850000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034215464), received between May 19, 2020 and Dec 12, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  STILL CONTAMINATED INSTRUMENTS AFTER REPROCESSING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789218 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. WHEN THE OPERATION WAS CARRIED OUT, IT WAS DISCOVERED THAT THE INSERTER WAS BROKEN INTO TWO PARTS. THE INNER SHAFT WAS NO LONGER IN CONTACT WITH THE HANDLE. THE OPERATION COULD BE CARRIED OUT AS USUAL. THE OPERATION TIME WAS NOT EXTENDED BY THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106027 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. WHEN THE OPERATION WAS CARRIED OUT, IT WAS DISCOVERED THAT THE INSERTER WAS BROKEN INTO TWO PARTS. THE INNER SHAFT WAS NO LONGER IN CONTACT WITH THE HANDLE. THE OPERATION COULD BE CARRIED OUT AS USUAL. THE OPERATION TIME WAS NOT EXTENDED BY THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106026 ↗
• MalfunctionApr 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FIXATION PIN INSERTER IS NOT RETAINING THE PINS. UNKNOWN IF SURGERY WAS DELAYED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) SKY TFP INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197266 ↗
• MalfunctionFeb 13, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  SHAFT BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694308 ↗
• MalfunctionFeb 13, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  SHAFT BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 18694307 ↗
• MalfunctionAug 10, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON JULY 25, 2023, THE TEMPORARY FIXATION PIN INSERTER FROM OUR SKYLINE SIEVE HAS APPARENTLY BEEN COMPLETELY BROKEN APART AT OUR ZSVA AND DISMANTLED INTO THREE PARTS. NO PATIENT HARM. THIS REPORT IS FOR ONE (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TEMPORARY FIXATION PIN - INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503292 ↗
• MalfunctionAug 10, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TEMPORARY FIXATION PIN INSERTER FROM OUR SKYLINE SIEVE HAS APPARENTLY BEEN COMPLETELY BROKEN APART AT OUR ZSVA AND DISMANTLED INTO THREE PARTS. NO PATIENT HARM. THIS REPORT IS FOR ONE (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TEMPORARY FIXATION PIN - INSERTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503289 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING SURGERY, IT WAS NOTICED THAT THE TEMPORARY PIN DRIVER BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE RETAINED IN THE PATIENT'S BODY. THIS REPORT INVOLVES ONE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TEMPORARY FIXATION PIN - INSERTER . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536231 ↗
• MalfunctionFeb 9, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS DIRTY. THE DEVICE IS PART OF LOAN SET AND IT WAS DECONTAMINATED IN MIELE MACHINE IN LOC DC. THE SURGERY WAS EXTENDED SINCE THE INSTRUMENT WAS NOT OPERATIONAL. THERE WAS A CHANGE IN THE SURGICAL METHOD AS IT WAS NOT POSSIBLE TO USE THE INSTRUMENT TO PLACE THE TEMPORARY FIXATION PINS. IT WAS NECESSARY TO USE GUIDES AND DRILLS TO ACHIEVE THE SAME PURPOSE, BUT THIS ACTION INVOLVED USING MORE INSTRUMENTS IN THE LITTLE SPACE AVAILABLE AND GENERATED MORE BONE INVASION. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TEMPORARY FIXATION PIN - INSERTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502061 ↗
• MalfunctionAug 25, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PIN INSERTER BROKE OFF INTRAOPERATIVELY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SKY TFP INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10450906 ↗
• MalfunctionMay 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE TEMPORARY FIXATION PIN INSERTER CANNOT BE DISASSEMBLED. THE INSTRUCTIONS FOR USE (IFU) SUGGESTS A PH VALUE OF 7 - 9 TO CLEAN THE INSTRUMENT BUT THE CUSTOMER NEEDS AN APPROVAL TO CLEAN THE INSTRUMENT WITH A PH VALUE OF GREATER THAN (>) 10. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SKY TFP INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10071711 ↗