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

Catalog Number 39-MT-0301

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

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 2 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.

• Brand Name: MODULAR POLYAXIAL TULIP ASSEMBLIES
• Type of Device: PEDICLE 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 Key: 8061900
• MDR Text Key: 126922626
• Report Number: 3005739886-2018-00052
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• 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 Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 39-MT-0301
• Device Lot Number: 13049PS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention