Spine InstrumentsRecalls & reported problems across all models
Medacta International SA · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 28 models of Spine Instruments by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2018 and Jun 17, 2026 — classified as 6 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Fracture” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Spine Instruments problems
Device problems
- Fracture18
- Material Fragmentation10
- Break7
- Solder Joint Fracture3
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
Patient problems
- No Known Impact Or Consequence To Patient14
- No Clinical Signs, Symptoms or Conditions13
- Foreign Body In Patient6
- Device Embedded In Tissue or Plaque4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Failure of Implant2
- Bone Fracture(s)1
- Eye Injury1
Spine Instruments models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Spine Instruments 03.52.10.0406Orthopedic Manual Surgical Instrument5 reports
- Spine Instruments 03.51.10.0222Orthopedic Manual Surgical Instrument4 reports
- Spine Instruments 03.30.10.0013Orthopedic Manual Surgical Instrument3 reports
- Spine Instruments 03.51.10.0182Orthopedic Manual Surgical Instrument3 reports
- Spine Instruments 03.51.10.0136Orthopedic Manual Surgical Instrument2 reports
- Spine Instruments 03.75.10.0060Orthopedic Manual Surgical Instrument2 reports
- Spine Instruments 03.51.10.0240Orthopedic Manual Surgical Instrument2 reports
- Spine Instruments 03.51.10.0490Orthopedic Manual Surgical Instrument2 reports
- Spine Instruments 03.51.10.0583Orthopedic Manual Surgical Instrument2 reports
- Spine Instruments 03.22.10.0055Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.30.10.1050Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.51.10.8500Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.52.10.0723Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.52.10.0401Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.52.10.0420Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.52.10.0202Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.75.10.0014Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.75.10.0041Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.75.10.0069Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.51.10.0550Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.51.10.1148Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.65.10.0038Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.29.10.1010Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.51.10.0183Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.22.10.7041Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.51.10.0600Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.51.10.0601Orthopedic Manual Surgical Instrument1 report
- Spine Instruments 03.51.10.0622Orthopedic Manual Surgical Instrument1 report
Recent Spine Instruments adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Fracture
THE TIP OF THE D 4.5 AGGRESSIVE REINFORCED UNDERSIZED TAP FRACTURED DURING USE IN HIGHLY SCLEROTIC BONE. THE BROKEN FRAGMENT WAS SUCCESSFULLY LOCATED AND REMOVED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED PATIENT HARM. 40-MINUTE DELAY (180 MIN TOTAL SURGERY TIME).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25528752 ↗MalfunctionJan 13, 2026Fracture
THE TIP OF THE MECTALIF POSTERIOR/OBLIQUE INSERTER INNER ROD BROKE DURING POSTERIOR OBLIQUE CAGE INSERTION. THE BROKEN PIECE COULD NOT BE REMOVED AND WAS LEFT INSIDE THE CAGE. THE PATIENT IS DOING WELL AT THE MOMENT, AND NO ACTION IS PLANNED.
Patient problems: Foreign Body In Patient
MAUDE report 24051156 ↗MalfunctionNov 21, 2025Fracture; Fracture
DURING SPINE SURGERY IN L5-S1 WHILE INSERTING A SCREW IN L5 THE TIP OF THE SCREWDRIVER BROKE. NO TAP WAS PERFORMED. BROKEN TIP WAS RECOVERED AND SCREW POSITION WAS CONSIDERED ALREADY GOOD. A BACKUP SCREWDRIVER WAS USED TO COMPLETE THE SURGERY. MOREOVER, DURING PREPARATION OF THE S1 LEFT TRAJECTORY, THE LENKE PROBE BROKE; THE BROKEN PART WAS LEFT IN THE PATIENT, DUE TO THE IMPOSSIBILITY TO REMOVE IT. NO HAMMERING, BENDING OR FLEXING OF THE PROBE WAS REPORTED. THE REPORTED ISSUES CAUSED A 30 MINUTE DELAY OVER A 3H SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23615341 ↗MalfunctionNov 19, 2025Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture
DURING SPINAL MIS SURGERY, THE TIP OF A SCREWDRIVER BROKE WHILE IMPLANTING THE THIRD PEDICLE SCREW (SURGICAL TECNIQUE FOLLOWED, AWL, WIRE AND TAP USED), CAUSING SLIGHT DAMAGE TO THE SCREW TULIP AND MAKING THE INSTRUMENT UNUSABLE. THE SURGERY WAS NOT AFFECTED, AS A SPARE SCREWDRIVER WAS AVAILABLE, AND NO HARM OCCURRED TO THE PATIENT. THE OPERATED LEVELS WERE L4-L5. THE PATIENT'S BONE QUALITY WAS GOOD, WITH NO SIGNS OF OSTEOPOROSIS OR ABNORMAL DENSITY. A NEW SCREW (SIZE UNKNOWN) WAS OPENED AND USED BECAUSE THE DAMAGED SCREW SHOWED MINOR DENTING, EVEN THOUGH NO FRAGMENT REMAINED ATTACHED TO THE IMPLANT. THE SURGEON PERFORMED A MINI-OPEN APPROACH (CUT EXTENSION), USED A PEDICLE AWL AND PEDICLE PROBE LUMBAR, TO POSITION THE NEW SCREW. NO PART OF THE INSTRUMENT REMAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591140 ↗MalfunctionOct 30, 2025Fracture; Fracture
DURING INSERTION OF A 6X45MM SCREW IN S1 THE TIP OF THE SCREWDRIVER BROKE INSIDE THE SCREW HEAD. SURGEON USED A TULIP AND A 35MM ROD TO EXTRACT THE SCREW. BACKUP SCREW (6X45MM) AND SCREWDRIVER WERE USED TO COMPLETE THE SURGERY. 30 MINUTES OF DELAY REPORTED OVER 2H30 OF SURGERY TIME. BONE QUALITY WAS REPORTED TO BE NORMAL. STANDARD TAPPING WAS PERFORMED, 6MM (GREEN COLORED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424080 ↗MalfunctionMar 28, 2025Fracture; Fracture
DURING L1-S2-SI SURGERY, THE SURGEON MALLETED THE LEKE PROBE IN RIGHT L2 AND THE TIP OF THE DEVICE BROKE IN THE PEDICLE. A TREPHINE ALONG WITH A PAIR OF VICE GRIPS WAS UTILIZED TO REMOVE THE BROKEN TIP. BONE QUALITY WAS REPORTED NOT BEING SCLEROTIC BUT ISSUE IN ADVANCING THE GEAR SHIFT THAT REQUIRED MALLETING. SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF DELAY ON 4 HOURS OF SURGERY. 7.0MM (DIAMETER) X55MM (LENGTH) SCREW WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21718316 ↗MalfunctionJul 26, 2024Break; Break
DURING THE INSERTION OF THE PEDICLE SCREW 9X40MM AT RIGHT SIDE OF S1, THE TIP OF THE SCREWDRIVER BROKE. THE SURGEON WAS NOT ABLE TO RETRIEVE THE BROKEN TIP FROM THE PEDICLE SCREW HEAD, SO THE BROKEN TIP WAS REMAINED IN THE PATIENT BODY, AND FINISHED THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19836978 ↗MalfunctionMay 2, 2024Fracture; Fracture
DURING A SPINE SURGERY PERFORMED FOR SCOLIOSIS CORRECTION, ONE OF THE TEETH OF TWO REDUCTION DEVICES BROKE WHILE EXECUTING THE CORRECTION.THESE METAL FRAGMENTS FROM BOTH THE INSTRUMENTS REMAINED IN THE PATIENT AND ARE VISIBLE FROM THE X-RAYS. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY USING BACK UP INSTRUMENTS AND NO DELAY HAS BEEN REPORTED. TOTAL TIME OF THE SURGERY WAS APPROXIMATELY 3 HOURS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19228465 ↗InjuryApr 30, 2024Fracture; Fracture
DURING A SPINE SURGERY PERFORMED FOR SCOLIOSIS CORRECTION, ONE OF THE TEETH OF SIX REDUCTION DEVICES BROKE WHILE EXECUTING THE CORRECTION. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY USING BACK UP INSTRUMENTS AND NO DELAY HAS BEEN REPORTED. TOTAL TIME OF THE SURGERY WAS APPROXIMATELY 2 HOURS AND 30 MINUTES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19211478 ↗MalfunctionApr 11, 2024Fracture; Fracture
DURING THE SURGERY (L3-S1), THE CURVED PROBE BROKE, WHILE PREPARING THE FIRST SCREW BONE. THE BROKEN PART WAS RECOVERED BY THE BONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PEDICLE SCREW WAS 6MM Ø X 50MM LENGTH. THE PATIENT BONE WAS VERY DENSE. THE SURGEON TOOK 20 MINUTES (TOTAL SURGERY TIME 2H AND 20 MINUTES) TO RETRIEVE THE FRAGMENT THAT WAS IN THE PEDICLE, HE USED A BURR AND A RONGEUR AND RETRIEVED THE FRAGMENT AND THEN USED 45 AND 50 TAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19086151 ↗MalfunctionApr 11, 2024Fracture; Fracture
THE PLATINE PART OF 8 DIFFERENT LOCKING TOWER ENH 2019 WAS BROKEN DURING SURGERY. DELAY TIME 1 HOUR AND A HALF (TOTAL TIME 4 HOURS). SURGERY COMPLETED SUCCESSFULLY ANYWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19086099 ↗MalfunctionNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING C2-T5 SPINAL FIXATION SURGERY, AT C7 LEVEL, DURING THE ROD REDUCTION PROCEDURE, THE MUST MINI REDUCTION DEVICE - SHORT AND ROD REDUCTION DEVICES WERE DISENGAGED FROM THE PEDICLE SCREW. THE REDUCTION DISTANCE TO PERFORM WAS ABOUT 3 MM. THE SURGEON PERFORMED THE ROD BENDING AGAIN AND COMPLETED THE SURGERY WITHOUT USING THE REDUCTION DEVICES. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 1 HOUR. TOTAL SURGERY TIME WAS ABOUT 5 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18091465 ↗MalfunctionSep 12, 2023Solder Joint Fracture; Solder Joint Fracture
DURING SURGERY THE TIP OF THE MUST PEDICLE SCREWDRIVER BROKE. THE SURGERY WAS DELAYED OF 3 HOURS IN ORDER TO REMOVE THE PEDICLE SCREW BECAUSE THE INSTRUMENT TIP WAS STUCK IN THE TULIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17729257 ↗MalfunctionAug 31, 2023Fracture; Fracture
THE PATIENT UNDERGONE L4-L5 SURGERY, THAT WAS A REVISION OF COMPETITOR'S IMPLANTS. THE 6.5MM COMPETITOR'S SCREW IN L4 LEFT WAS REMOVED AND TAPPING WITH MUST SOLID TAP WAS PERFORMED (7MM -> 8MM -> 10MM) IN ORDER TO INSERT THE PEDICLE SCREW 10X50MM. DURING THE INSERTION, THE TIP OF TWO MUST PEDICLE SCREWDRIVER - MIS HYBRID WERE FRACTURED. THE TWO AVAILABLE BONE SCREWDRIVERS WERE USED TO REMOVE THE SCREW, BUT BOTH WERE FRACTURED. OTHER SCREWDRIVERS WERE NOT AVAILABLE AND THE THREAD OF SCREW HEAD WAS DAMAGED AND FOR THIS REASON, IT WAS NOT POSSIBLE TO INSERT THE SET SCREW IN ORDER TO FIX THE ROD AND REMOVE THE PEDICLE SCREW. L4-L5 SCREWS ON THE RIGHT SIDE WERE IMPLANTED. THE PEDICLE SCREW ON THE LEFT SIDE WAS LEFT IN THE BODY WITHOUT SET SCREW. THE SURGERY WAS COMPLETED WITH 30MIN DELAY TIME BECAUSE OF THE REPORTED ISSUES. THE BONE WAS REPORTED TO BE A LITTLE FRAGILE. THE REVISION SURGERY WAS CONDUCTED ON THE 8TH OF AUGUST. THE PEDICLE SCREW WAS REMOVED, AND NEW SCREW (REF. 03.50.092) WAS REPLACED WITH IT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17661081 ↗MalfunctionAug 10, 2023Fracture; Fracture
DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON WAS CUTTING THE COCR ROD WITH A ROD CUTTER, A PIECE OF THE ROD CUTTER FLEW INTO THE AIR AND HIT THE OR LIGHT WHICH SHATTERED AND RESULTED IN PIECES OF GLASS FALLING INTO THE STERILE FIELD. THE OR LIGHT WAS REMOVED AND THE SURGEON BACKED OUT OF THE OR AND SCRUBBED IN AGAIN, IRRIGATED THE PATIENT EXTENSIVELY AND APPLIED AN ANTIMICROBIAL WOUND LAVAGE TO THE OPEN INCISION. THE SURGEON HAD TO USE COMPETITOR ROD CUTTER TO COMPLETE THE CASE. THERE WAS 30-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17498529 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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