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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRECISION SPINE, INC. MODULAR POLYAXIAL TULIP ASSEMBILES PEDICLE SCREW SPINAL SYSTEM

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PRECISION SPINE, INC. MODULAR POLYAXIAL TULIP ASSEMBILES PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 39-MT-0301
Device Problem Component Incompatible (1108)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The root cause is attributed to mis-labeling of product returned to distribution. A capa was initiated for investigation and corrective actions. This report is number 6 of 6 mdrs filed for the same event (reference 3005739886-2018-00045).
 
Event Description
Sales representative indicated that during attempted assembly in the distributors office of six modular polyaxial tulip assemblies from lot 13049ps, it was identified that the mating rod component would not function in the tulip. There was no patient involvement as this was identified in the office prior to loading into the trays and taken into surgery.
 
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Brand NameMODULAR POLYAXIAL TULIP ASSEMBILES
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
PRECISION SPINE, INC.
2050 executive dr
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 Key8061817
MDR Text Key128406587
Report Number3005739886-2018-00050
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number39-MT-0301
Device Lot Number13049PS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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