MAUDE Adverse Event Report: PRECISION SPINE, INC 55MM X 40MM S-LOK POLYAXIAL SCREW

Catalog Number SLP5540

Device Problems Break (1069); Failure to Align (2522); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

Device is expected to be returned to the manufacturer for evaluation.A follow-up medwatch report will be submitted upon completion of the investigation.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2016-00037 / 00038).

Event Description

It was reported that the patient underwent initial procedure in the (b)(6) on (b)(6) 2016 during which eight s-lok pedicle screws and two cages were implanted.While still admitted, the patient underwent a second procedure on (b)(6), in which two screw were repositioned due to malalignment (l5 & s1 right side).The patient was discharged and returned two months postoperative with c/o pain in her backside, at which time radiographs were taken indicating one 55mm x 40mm s-lok polyaxial screw and one 55mm x 35mm s-lok polyaxial screw are broken, mid shaft.Revision was performed on (b)(6) 2016 to remove the broken screws.

Manufacturer Narrative

Engineering evaluation of the returned screws, along with radiographs and information provided indicate that screw breakage appears to be the result of fatigue loading.The root cause of the fracture could not be definitively determined but are likely due to the loading conditions, and the fixation that existed prior to screw breakage.Review of manufacturing history records found a total of (b)(4) pieces of this lot released for distribution on 1/19/2016 with no deviation or anomalies.A three year complaint history review did not find any previous reports of this nature for this lot.Further review of all part numbers in the slpxxxx family of s-lok polyaxial pedicle screws did not identify a trend for reports of this nature.A need for corrective action was not identified.Device fracture is a known risk of this procedure.The associated package insert, surelok pedicle screw system ((b)(4)) states under potential adverse effects: "7.Device component fracture" and under warnings: "3.Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebrae, neurological injury, and vascular or visceral injury." this report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2016-00037-1 & 00038-1).

• Brand Name: 55MM X 40MM S-LOK POLYAXIAL SCREW
• Type of Device: POLYAXIAL SCREW
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 5815368
• MDR Text Key: 50207489
• Report Number: 3005739886-2016-00037
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: K092128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SLP5540
• Device Lot Number: 8708PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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