PRECICE Bone Transport SystemRecalls & reported problems across all models
Nuvasive Specialized Orthopedics, Inc. · 561 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one PRECICE Bone Transport System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 3
We found 561 models of PRECICE Bone Transport System by Nuvasive Specialized Orthopedics, Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2019 and Mar 18, 2026 — classified as 13 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
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
PRECICE Bone Transport System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 29, 2021Open, Classified
The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
Z-0319-2022 · Root cause: Device Design · names 15 of these models · Recall details · FDA record ↗
- Feb 12, 2021Open, Classified
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Z-1324-2021 · Root cause: Under Investigation by firm · names 561 of these models · Recall details · FDA record ↗
- Feb 12, 2021Open, Classified
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Z-1323-2021 · Root cause: Under Investigation by firm · names 561 of these models · Recall details · FDA record ↗
Most reported PRECICE Bone Transport System problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Fracture4
- Break3
- Defective Device3
- Detachment of Device or Device Component3
- Failure to Advance3
- Mechanical Problem3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Failure of Implant16
- No Clinical Signs, Symptoms or Conditions6
- Unspecified Infection3
- Bone Fracture(s)2
- Implant Pain1
- Insufficient Information1
- Pain1
- Skin Discoloration1
PRECICE Bone Transport System models
561 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PRECICE® Bone Transport System STP3.5-200Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-250Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-275Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-325Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-375Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-425Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-450Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-475Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-500Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-550Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-600Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System BT13-10X400-7Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® Bone Transport System BT115-10SJ360-7Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® Bone Transport System BT10-10D380-7Rod, Fixation, Intramedullary And Accessories2 recalls3 reports
- PRECICE® Bone Transport System BT115-10SJ400-7Rod, Fixation, Intramedullary And Accessories2 recalls2 reports
- PRECICE® Bone Transport System BT115-10D400-7Rod, Fixation, Intramedullary And Accessories2 recalls2 reports
- PRECICE® Bone Transport System BT10-90SJ340-5Rod, Fixation, Intramedullary And Accessories2 recalls2 reports
- PRECICE® Bone Transport System BT13-10B400-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT115-80SJ320-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT115-70SJ300-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT115-10X400-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT115-10X380-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT115-10D380-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT115-10B380-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT10-90X340-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT10-90SJ340-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT10-90B340-5Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT10-80D320-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT10-10X400-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT10-10SJ380-7Rod, Fixation, Intramedullary And Accessories2 recalls1 report
- PRECICE® Bone Transport System BT13-90X340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90X340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90V340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90V340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SJ340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SJ340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SE340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SE340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SD340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SD340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SB340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SB340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SA340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90SA340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90E340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90E340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90DT340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90DT340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90D340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90D340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90C340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90C340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90BT340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90BT340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90B340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90B340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90A340-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-90A340-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80X320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80X320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80V320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80V320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SJ320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SJ320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SE320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SE320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SD320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SD320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SB320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SB320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SA320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80SA320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80E320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80E320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80DT320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80DT320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80D320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80D320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80C320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80C320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80BT320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80BT320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80B320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80B320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80A320-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-80A320-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70X300-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70X300-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70V300-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70V300-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70SJ300-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70SJ300-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70SE300-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70SE300-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70SD300-7Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
- PRECICE® Bone Transport System BT13-70SD300-5Rod, Fixation, Intramedullary And Accessories2 recalls0 reports
Recent PRECICE Bone Transport System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Break
IT WAS REPORTED THAT A PRECICE BONE TRANSPORT, RETROGRADE FEMUR NAIL HAS BROKEN DUE TO INSUFFICIENT BONE HEALING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24627662 ↗MalfunctionJan 23, 2026Failure to Advance
IT WAS REPORTED THAT AFTER THE INITIAL OR DATE ON (B)(6) 2025 WHERE THE ANTEGRADE IMPLANTATION WAS PERFORMED WITH RETROGRADE TRANSPORT BY USING A CABLE WIRE. THE SLOT WAS MOVED DISTALLY USING FDM. A SURGICAL TOWEL WAS PLACED BETWEEN NAIL AND FDM. THE MANEUVER FUNCTIONED WITHOUT DIFFICULTY. THE IMPLANTATION OF THE NAIL PROCEEDED AS EXPECTED, MARKING THE MAGNET. THEN ON (B)(6) 2025 THERE WAS THE PATIENT ERC4 INTRODUCTION. WE RENEWED CONTACT ON (B)(6) 2025 WHERE THE SURGEON NOTICED THE INCOMPLETE OSTEOTOMY. ON (B)(6) 2025 WE HAD THE REVISION PROCEDURE. THIS INCLUDED THE COMPLETION OF THE OSTEOTOMY. AND FOLLOWING COMPLETION OF THE OSTEOTOMY, THE FAST DISTRACTOR MAX WAS APPLIED IN AN ATTEMPT TO MOVE THE SLOT. THE DEVICE WAS MAINTAINED AT THE MARKED POSITION FOR A MINIMUM OF 5 MINUTES UNDER XRAY CONTROL. NO MOVEMENT OF THE SLOT WAS OBSERVED. SUBSEQUENTLY, THE ERC 4 WAS APPLIED IN AN ADDITIONAL ATTEMPT TO ACTIVE THE SLOT MOVEMENT. AGAIN, NO MOVEMENT WAS DETECTED. THE CABLE WIRE WAS REMOVED. BASED ON INTRAOPERATIVE FINDINGS, NAIL EXCHANGE WAS DEEMED NOT SURGICALLY FEASIBLE. THE BONE TRANSPORT WILL NOW BE PERFORMED USING AN EXTERNAL RING FIXATOR. ADDITIONALLY, REGARDING REVISION SURGERY WE
Patient problems: Failure of Implant
MAUDE report 24167402 ↗MalfunctionDec 22, 2025Failure to Advance; Failure to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT ANKLE ARTHRODESIS, AND A BONE TRANSPORT FEMUR NAIL, PREVIOUSLY PLANNED BY THE SURGEON, WAS IMPLANTED. DURING POSTOPERATIVE FOLLOW-UP, IT WAS OBSERVED THAT THE IMPLANT WAS NOT FUNCTIONING. A NEW SURGERY WAS SCHEDULED FOR (B)(6) 2025. THE IMPLANT WAS CHECKED BOTH INSIDE AND OUTSIDE THE PATIENT USING A FAST DISTRACTOR AND WITH ERC (ELECTROMAGNETIC RESONANCE IMAGING), AND THE MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. THEREFORE, IT WAS DECIDED TO REPLACE IT WITH A NEW ONE, WHICH ULTIMATELY DID FUNCTION. THE DELAY IN REPORTING THE INCIDENT WAS DUE TO THE HOSPITAL FIRST DECONTAMINATING THE NAIL, AND THEN SEVERAL INTERNAL COMMUNICATION ERRORS (AN INTERNAL NON-CONFORMITY REPORT HAS BEEN FILED REGARDING THIS ISSUE, AND TRAINING WILL BE PROVIDED).
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23865365 ↗InjuryNov 6, 2024Fracture; Fracture
THE INFORMATION RECEIVED INDICATES THAT A REVISION PROCEDURE WAS PERFORMED FOLLOWING THE PATIENT¿S REPORT OF IMPLANT-RELATED PAIN. RADIOGRAPHIC IMAGING CONFIRMED THAT THE IMPLANT HAD FRACTURED. THE PATIENT REPORTED THAT NO TRAUMATIC EVENT PRECEDED THE FRACTURE. THE PATIENT'S MEDICAL HISTORY INCLUDES TREATMENT FOR A LEFT FEMUR FRACTURE UTILIZING AN EXTERNAL FIXATOR IN (B)(6) 2024, FOLLOWED BY MANAGEMENT OF BONE LOSS THROUGH THE TWO-STAGE MASQUELET TECHNIQUE.
Patient problems: Implant Pain
MAUDE report 20623364 ↗InjuryJun 8, 2024Failure to Advance; Failure to Advance
INFORMATION WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE THE HOSPITAL DID NOT HAVE THE RIGHT S-GUIDE FOR THE NAIL. THE NAIL WAS CLEANED AND SAVED FOR IMPLANT A FEW DAYS LATER. BEFORE IMPLANTING THE NAIL AGAIN, IT WAS TESTED WITH THE FAST DISTRACTOR AND IT WOULD NOT DISTRACT. A NEW NAIL WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Failure of Implant
MAUDE report 19493912 ↗InjuryMar 11, 2024Break; Break
INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED WITH PAIN IN THE KNEE. X-RAY EXAMINATION REPORTEDLY REVEALED THE IMPLANT WAS FRACTURED. PER THE REPORTER, THE PATIENT DID NOT REGULARLY ATTEND THE SCHEDULED X-RAY EXAMINATIONS TO CHECK, THEREFORE, THE DOCKING SITE AND PSEUDOATRHROSIS COULD NOT BE CHECKED BY THE PHYSICIAN FOR A LONG TIME. THE PATIENT DENIED HAVING HAD ANY FALLS. A REVISION PROCEDURE WAS PERFORMED AND THE NAIL WAS EXPLANTED. THE PATIENT WAS REPORTED TO HAVE BEEN FULL WEIGHT BEARING BEYOND THE INSTRUCTIONS FOR USE (IFU). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 18880613 ↗MalfunctionJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17164693 ↗MalfunctionMar 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16512629 ↗MalfunctionJun 24, 2022Fracture; Fracture
INFORMATION WAS RECEIVED THAT X-RAY IMAGES SHOWED THE NAIL HAD BROKEN IN-SITU. THE PATIENT WAS FULL WEIGHT BEARING ON THE NAIL AS A BUILDER POST CONSOLIDATION. THE NAIL HAS BEEN EXPLANTED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14803165 ↗MalfunctionJun 22, 2022Break; Crack; Break; Crack
INFORMATION WAS RECEIVED THAT X-RAYS SHOWED A CRACK JUST DISTAL TO THE TRANSPORT SCREW THAT IS AT THE END OF THE DISTAL SLOT. DURING THE EXPLANT PROCEDURE THE NAIL BROKE WHERE THE DEFECT WAS VISIBLE AND WAS DIFFICULT TO REMOVE. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 14775462 ↗MalfunctionMar 29, 2022Fracture; Off-Label Use; Fracture; Off-Label Use
INFORMATION WAS RECEIVED THAT WHILE RETRACTING THE NAIL TO SEE IF IT STILL WORKED, IT WAS NOTED ON THE INTRA-OPERATIVE X-RAYS, THAT THE NAIL WAS BROKEN INTO TWO SEGMENTS. THE NAIL WAS STILL FUNCTIONAL, AND THE SURGEON OPTED TO RETRACT THE NAIL AND LEAVE IT IN-SITU TO CONTINUE BONE TRANSPORT OF THE PATIENT'S FEMUR. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13938754 ↗MalfunctionJul 7, 2021Fracture; Fracture
INFORMATION WAS RECEIVED THAT DURING EXPLANTATION, A BROKEN NAIL AND FIXATION SCREW WERE OBSERVED. NO PATIENT IMPACT WAS REPORTED. REPORT 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12131903 ↗InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 11731736 ↗InjuryApr 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11613459 ↗InjuryMar 30, 2021Disconnection; Disconnection
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE PATIENT SUFFERING FROM A PERI-PROSTHETIC FRACTURE AROUND THE PROXIMAL NAIL SCREWS WHICH RESULTED IN A LOSS OF ALIGNMENT. ADDITIONALLY, DURING REMOVAL OF THE NAIL, THE NAIL DISASSOCIATED. IT WAS REPORTED THAT INSTEAD OF A RETENTION PLUG, THE SURGEON USED A UNILATERAL EXTERNAL FIXATOR TO HOLD ALL SEGMENTS DURING NAIL REMOVAL, WITH THE PROXIMAL APEX PIN INSERTED IN CLOSE PROXIMITY TO THE NAIL.
Patient problems: Bone Fracture(s)
MAUDE report 11592875 ↗
Other Nuvasive Specialized Orthopedics, Inc. products
- MAGEC Spinal Bracing and Distraction System29 models · 663 reports · 1 recall
- PRECICE Intramedullary Limb Lengthening System551 models · 177 reports · 4 recalls
- PRECICE STRYDE System231 models · 139 reports · 2 recalls
- PRECICE Plating System67 models · 24 reports · 3 recalls
- PRECICE Trauma Nail System182 models · 4 reports · 3 recalls
- FREEDOM Residual Limb Lengthening System2 models · 1 reports · 2 recalls
- Precice38 models · 9 reports · 1 recall
- PRECICE System15 models · 0 reports · 1 recall
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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