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U.S. Department of Health and Human Services

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

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PRECISION SPINE, INC. MODULAR POLYAXIAL TULIP ASSEMBLIES PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 39-MT-0301
Device Problems Difficult to Insert (1316); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  Injury  
Manufacturer Narrative

Evaluation of product from the same lot found the root cause is attributed to mis-labeling of product returned to distribution. A capa was initiated for investigation and corrective action. This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2018-00051 / 00052).

 
Event Description

It was reported that during a procedure on an unknown date in (b)(6), upon attempts to insert the rod it was identified that it would not fit in two (2) of the modular polyaxial tulip assembiles (39-mt-0301). The two (2) screw/tulip assemblies were removed from the patient and replaced with other product readily available in the set. The removed screws/tulips were discarded at the hospital. There was no injury to the patient as a result of this malfunction.

 
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Brand NameMODULAR POLYAXIAL TULIP ASSEMBLIES
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 Key8061827
MDR Text Key126922689
Report Number3005739886-2018-00051
Device Sequence Number0
Product Code NKB
Combination Product (Y/N)
Reporter Country CodeUS
PMA/PMN NumberK150856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 10/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2018
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number39-MT-0301
Device LOT Number13049PS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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

Patient TREATMENT DATA
Date Received: 11/12/2018 Patient Sequence Number: 1
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