MAUDE Adverse Event Report: PRECISION SPINE, INC. S-LOK POLYAXIAL SCREW; PEDICLE SCREW SPINAL SYSTEM

Catalog Number SLP6550

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

Other serious (important medical events) - this is being reported as a serious injury due to the implanted screws breaking causing the need for a revision procedure performed on (b)(6) 2017.Evaluation of the returned device by engineering determined that the screws were removed after two years and two months of implantation.The failures appear to be fatigue related.The cause for these failures is not known.Review of manufacturing history records found a large quantity of lot 6186pm were released into distribution on 04/11/2012 with deviations or anomalies.Review of complaint history did not reveal a trend for reports of this nature for this part number.The need for corrective action was not indicated.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2017-00051).

Event Description

During a routine follow-up exam the doctor discovered two (2) broken s-lok screws that had been previously implanted on (b)(6) 2015.Hardware removal case was completed on (b)(6) 2017 where two (2) broken s-lok screws were removed.Doctor did not replace the broken hardware in the patient.

• Brand Name: S-LOK POLYAXIAL SCREW
• 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
• MDR Report Key: 6859616
• MDR Text Key: 85859733
• Report Number: 3005739886-2017-00052
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090033
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SLP6550
• Device Lot Number: 4194TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2012
• 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): Other