MAUDE Adverse Event Report: PRECISON SPINE, INC REFORM 6.5 X 45MM POLYAXIAL PEDICLE SCREW; MNH, MNI

Catalog Number 39-PA-6545

Device Problems Device Damaged by Another Device (2915); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2014

Event Type  Injury  

Event Description

It was reported that during a l3-s1 procedure performed on (b)(6) 2014, while seating the 6.5 x 45m reform polyaxial screw ((b)(4)), the screwdriver got stuck in the head of the screw and the screw had to be removed from the patient.Upon disassembly of the driver from the screw (outside of the patient) the head of the screw broke off of the shaft.No delay to the procedure resulted.

Manufacturer Narrative

Engineering evaluation of the returned screw cannot duplicate the claim that the polyaxial driver would not unthread from the tulip of the screw; there is no evidence of this issue present in the returned components.In regards to the neck shearing on the screw there is not enough information to suggest there are any design or manufacturing issues present; it is not known how this exactly occurred, but that it was outside of the patient under abnormal conditions.Review of manufacturing records found a total of (b)(4) pieces of this lot were released for distribution in march of 2013.A 2-year complaint history review found this to be the first report of instrument sticking in the head of the screw.This report is #3 of 3 mdr's filed for the same event (ref#30057398896-2015-00034/36).

• Brand Name: REFORM 6.5 X 45MM POLYAXIAL PEDICLE SCREW
• Type of Device: MNH, MNI
• Manufacturer (Section D): PRECISON SPINE, INC; pearl MS
• Manufacturer Contact: 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 4634922
• MDR Text Key: 19800971
• Report Number: 3005739886-2015-00036
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39-PA-6545
• Device Lot Number: 0198BG
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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
• Patient Outcome(s): Required Intervention