MOSS 275010160Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034194073), received between Jun 23, 2017 and Apr 3, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT THE SOUNDING PROBE WAS BROKEN. IT HAPPENED DURING SURGERY AND OUTSIDE THE PATIENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT OR DELAYS IN SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767130 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT SINCE THIS OCCURRED PRE-OPERATIVELY. THIS REPORT INVOLVES ONE BALL TIP FEELER, STRAIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291613 ↗
• MalfunctionJul 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THERE WAS AN ALLEGATION FOUND DURING INSPECTION OF EQUIPMENT. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) MOSS MIAMI MAGNUM SPINE SYSTEM BALL TIP FEELER (CURVED) 6.35 10-100MM PLUS OR MINUS 4.00 PERCENT. THIS IS REPORT 14 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309488 ↗
• MalfunctionJun 20, 2023Break; Break

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE FINE TIP OF THE INSTRUMENT IN QUESTION BROKE WHEN THE SURGEON ATTEMPTED TO PALPATE THE PEDICLE. NO FRAGMENTS WERE GENERATED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MOSS MIAMI MAGNUM SPINE SYSTEM BALL TIP FEELER (CURVED) 6.35 10-100MM PLUS OR MINUS 4.00 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164565 ↗
• MalfunctionMay 22, 2023Break; Break

  SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT STATUS OR OUTCOME WAS AS EXPECTED. NO FRAGMENTS WERE RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16978726 ↗
• MalfunctionDec 29, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE OPERATING ROOM STAFF IDENTIFIED THE PEDICLE SOUND WAS MISSING THE DISTAL TIP PRE-OPERATIVELY. THE INSTRUMENT WAS NOT USED DURING THE OPERATION AND REMOVED FROM THE OPERATING ROOM. THE PEDICLE SOUND DISTAL END HAD BEEN SEVERED AND WAS NOT ON THE INSTRUMENT, IT CONFIRMED NOT PRESENT IN THE TRAY DURING INCIDENT. THE REPROCESSING AREA WAS SEARCHED AND STILL WAS NOT FOUND. THE SOUND WAS REMOVED AND SENT TO THE COMPLAINTS DEPARTMENT. THERE WAS NO REPORTED PATIENT INTERACTION. THIS REPORT IS FOR A MOSS MIAMI MAGNUM SPINE SYSTEM BALL TIP FEELER (CURVED) 6.35 10-100MM +/- 4.00% THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073138 ↗
• MalfunctionOct 22, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE SURGERY, AN INSTRUMENT BROKE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. SURGICAL DELAY IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9219310 ↗
• MalfunctionAug 27, 2019Break; Break

  DISTAL TIP OF PEDICLE FEELER BROKE WHEN SURGEON WAS PALPATING THE PEDICLE WALLS. DISTAL TIP FRAGMENT WAS RETRIEVED. NO FRAGMENTS LEFT IN THE PATIENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936550 ↗
• MalfunctionSep 29, 2017Break; Break

  L4-S1 POSTERIOR LUMBAR INTERBODY FUSION. 2797-02-010 X 1 STRAIGHT PEDICLE PROBE. THIS ITEM RESULTED IN A TWISTED TIP DURING USE ON THE PATIENT. THE INSTRUMENT DID NOT BREAK AND IS STILL INTACT. 2797-02-150 X 1 ERGONOMIC BLUE T-HANDLE. THIS ITEM HAS A DAMAGED SPRING CLIP THAT WAS DISCOVERED BEFORE USE ON THE PATIENT WHEN SETTING UP THE INSTRUMENTS BY THE NURSE. 2750-10-160 X 1 CURVED BALL TIP FEELER. THIS ITEM WAS FOUND TO HAVE A THE BALL TIP BROKEN OFF THE END BEFORE USE ON THE PATIENT WHEN SETTING UP THE INSTRUMENTS BY THE NURSE. 2867-15-350 X 1 RATCHETING MODULAR T-HANDLE. THIS ITEM HAS A DAMAGED SPRING CLIP THAT WAS DISCOVERED BEFORE USE ON THE PATIENT WHEN SETTING UP THE INSTRUMENTS BY THE NURSE. OTHER INSTRUMENTS WERE AVAILABLE IN A SECOND SET AT THE HOSPITAL TO COMPLETE THE SURGERY AND THE PATIENT WAS NOT AFFECTED IN ANY WAY. 'PRODUCT DISCARDED' HAS BEEN SELECTED FOR PRODUCT STATUS IN THIS INSTANCE AS THERE IS NO APPROPRIATE STATUS AVAILABLE TO REPRESENT THE FOLLOWING LOCAL PROCESS: INSTRUMENT WILL BE SENT TO LOCAL ENGINEERING FOR ASSESSMENT OF WEAR AND TEAR. IF 'WEAR AND TEAR' IS ASSIGNED, A COPY OF THE LOCAL ASSESSMENT WILL BE PROVIDED TO THE MANUFACTURER FOR THEIR RECORD A

  Patient problems: No Patient Involvement; Not Applicable

  MAUDE report 6903735 ↗
• MalfunctionSep 26, 2017Break; Break

  IT WAS REPORTED THAT THE SCRUB NURSE NOTED THAT THE BALLED TIP OF THE PROBE WAS MISSING. THIS OCCURRED BEFORE THE SURGEON HAD STARTED. COMPLETED WITH SAME/LIKE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6894022 ↗
• MalfunctionJun 23, 2017Break; Break

  THERE ARE 100+ ITEMS PLACED ON DC ORTHOKIT QUARANTINE DUE TO BREAKAGES, FUNCTIONAL TESTS FAILURES. THIRTY EIGHT PERTAIN TO DEPUY SPINE PRODUCTS. IN ALL CASES NO DATA AVAILABLE IF ANY INJURES OR ADVERSE EVENTS. NO INFORMATION ABOUT SURGERY, DELAYS, PATIENT RELATED DATA. ONLY PRODUCT CODE/LOT DESCRIPTION AND BREAKAGE DEFINITION IS AVAILABLE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6663434 ↗