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

Catalog Number 39-MT-0301

Device Problem Protective Measures Problem (3015)

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 3 of 6 mdrs filed for the same event (reference 3005739886-2018-00045 / 00050).

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.

• Brand Name: MODULAR POLYAXIAL TULIP ASSEMBILES
• 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: 8061811
• MDR Text Key: 127218956
• Report Number: 3005739886-2018-00047
• 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: 08/24/2018

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 39-MT-0301
• Device Lot Number: 13049PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 1