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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM; MODULAR MIS EXTENDED TAB TULIP
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PRECISION SPINE, INC REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM; MODULAR MIS EXTENDED TAB TULIP Back to Search Results
Model Number 64-MT-0403
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2022
Event Type  Injury  
Event Description
It was reported that a procedure was performed on (b)(6) 2022, in australia, utilizing the reform ti mis ct modular percutaneous screw system.Upon final tightening of one of the set screws, the modular polyaxial tulip assembly reform mis pedicle screw system (39-mt-0403) slowly moved up off of the screw and out of the patient.The screw was then removed, and a second screw and tulip were assembled and implanted with no further issue.There was a slight (a few minutes) delay to the procedure because of this malfunction, but no patient injury was reported.
 
Manufacturer Narrative
Patient information - unknown.Occupation - other; distributor.Type of reportable event - assessed as a serious injury due to medical intervention required to remove and replace the pedicle screw following the malfunction of the modular tulip.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
 
Event Description
It was reported that a procedure was performed on (b)(6) 2022, in australia, utilizing the reform ti mis ct modular percutaneous screw system.Upon final tightening of one of the set screws, the modular polyaxial tulip assembly reform mis pedicle screw system (39-mt-0403) slowly moved up off of the screw and out of the patient.The screw was then removed, and a second screw and tulip were assembled and implanted with no further issue.There was a slight (a few minutes) delay to the procedure because of this malfunction, but no patient injury was reported.
 
Manufacturer Narrative
H3: device evaluation: the modular tulip and screw were provided in an assembled state.No visible irregularities were ascertained, and the assembly remains securely fixed together which is indicative of the design intent.No further assessment of this part is planned.Functional assessment of other parts from this lot was not feasible since no tulips from this lot were available.The implant design was subsequently reviewed and compared to the predicate reform ti modular tulip design (39-mt-040x) upon which this design is based.This predicate design has been in use for nearly 3 years without the noted failure.Both designs share the same design configuration, and same bone screw assembly characteristics.Parts were subsequently pulled from another lot and functional assessments performed to try to reproduce the failure.No instance of disassembly of a fully assembled screw occurred.Based upon all of the above, the observed condition is likely due to improper screw - tulip assembly, and no corrective actions are being recommended at this time.
 
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Brand Name
REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM
Type of Device
MODULAR MIS EXTENDED TAB TULIP
Manufacturer (Section D)
PRECISION SPINE, INC
2050 executive drive
pearl MS 39208
Manufacturer (Section G)
PRECISION SPINE, INC.
2050 executive dr
pearl MS 39208
Manufacturer Contact
mike dawson
2050 executive dr
pearl, MS 39208
6014204244
MDR Report Key15041697
MDR Text Key296062571
Report Number3005739886-2022-00022
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840019940610
UDI-Public00840019940610
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K150856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number64-MT-0403
Device Catalogue Number64-MT-0403
Device Lot Number38854PS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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