Spider Cervical Plating System N60000160Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI M697N600001601), received between Mar 29, 2018 and May 28, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (7 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Fracture; Fracture

  THE MANUFACTURER WAS NOTIFIED OF A PRODUCT COMPLAINT ON 04/24/2025. IT WAS REPORTED THAT A SYSTEM SCREWDRIVER WAS REQUESTED TO BE REPLACED. DETALIS FROM THE COMPLAINANT WERE PROVIDED ON 04/29/2025, WHICH INFORMED THE MANUFACTURER THAT THE SYSTEM SCREWDRIVER WAS REQUESTED TO BE REPLACED DUE IT BREAKING DURING SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS OR DELAYS IN PROCEDURE ASSOCIATED WITH THIS COMPLAINT. A RETURN AUTHORIZATION WAS ISSUED FOR THE RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 04/29/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097721 ↗
• MalfunctionNov 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT A MALLET WAS USED TO TAP THE SCREW FORWARD, WHICH RESULTED IN THE FRACTURING OF THE DISTAL TIP OF THE SCREWDRIVER. NO PIECES WERE RETAINED BY THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695888 ↗
• MalfunctionJun 6, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6)2023. IT WAS REPORTED THAT THE DISTAL HEX TIP OF A SYSTEM SCREWDRIVER FRACTURED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT SCREWDRIVER, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON (B)(6)2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071517 ↗
• MalfunctionDec 20, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON (B)(6)2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE BEING ROTATED DURING AN ACDF PROCEDURE. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN AVAILABLE ALTERNATE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS EVENT. A RETURN AUTHORIZATION WAS PROVIDED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON (B)(6)2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016959 ↗
• MalfunctionSep 30, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON 9/02/2021 OF A SYSTEM SCREWDRIVER THAT HAD THE DISTAL TIP FRACTURE DURING A SURGICAL PROCEDURE WHEN TIGHTENING A SYSTEM SCREW. THE FRACTURED PORTION OF THE SCREWDRIVER WAS REMOVED FROM THE SURGICAL SITE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT INSTRUMENT ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 9/07/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558277 ↗
• MalfunctionMar 25, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON 3/18/2021 THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHEN BEING ROTATED DURING AN ACDF PROCEDURE ON (B)(6) 2021. THE FRACTURED PORTION OF THE INSTRUMENT WAS RECOVERED, AND THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN AVAILABLE ALTERNATE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572697 ↗
• MalfunctionSep 16, 2020Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON 8/20/2020 OF AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE A SYSTEM SCREW WAS ROTATED. THE FRACTURED PORTION OF THE COMPLAINT INSTRUMENT WAS REMOVED FROM THE SURGICAL SITE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10541049 ↗
• MalfunctionMay 27, 2020Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTICE ON 4/28/2020 REGARDING A SYSTEM SCREWDRIVER THAT WAS REQUESTED TO BE REPLACED DUE TO WEAR AND TEAR. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10094612 ↗
• MalfunctionMay 9, 2019Break; Break

  THE COMPLAINANT REPORTED THAT ONE SCREWDRIVER'S DISTAL TIP FRACTURED DURING SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8597707 ↗
• MalfunctionMar 7, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT THE DISTAL TIP OF THE SCREWDRIVER BROKE DURING A SURGERY. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400901 ↗
• MalfunctionFeb 6, 2019Fracture; Fracture

  THE COMPLAINANT REPORTED THAT THE DISTAL TIP OF A SCREW DRIVER BROKE WHEN THE FINAL SCREW WAS BEING TIGHTENED TO SECURE A CERVICAL PLATE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8312064 ↗
• MalfunctionMay 14, 2018Fracture; Fracture

  THE COMPLAINANT REPORTED THAT THE DISTAL TIP OF A SCREWDRIVER BROKE OFF WHEN TORQUING DOWN ON A SCREW DURING SURGERY. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7513063 ↗
• MalfunctionMar 29, 2018Fracture; Fracture

  THE COMPLAINANT REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF INSIDE THE SCREWHEAD. THE DRIVER BROKE WHEN THE SCREW WAS BEING TIGHTENED DOWN, AFTER IT PASSED THE LOCKING ARM. THERE ARE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381952 ↗