MAUDE Adverse Event Report: K2M, INC. MESA SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 801-06545

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 12/03/2016

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.

Event Description

It was reported to k2m, inc.On 12.06.2016 that the outer collet of a screw broke during rod reduction and had to be removed and replaced, causing a significant delay in the surgery.Surgery took place on (b)(6) 2016.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.There were markings on the remaining side of the inner collet consistent with use of the cricket rod reduction instrument including indications of possible instrument misalignment.The outer tulip head had deformation on one flange indicating only one contact point for the locker interface.There were no marks in the inner collet rod interface indicating the rod never nested properly.It is likely the screw was in a partial locked state prior to the attempted rod reduction and locking.The force of the rod pressing on the partial locked inner collet likely caused the collet fracture.

Event Description

It was reported to k2m, inc.On (b)(6) 2016 that the outer collet of a screw broke during rod reduction and had to be removed and replaced, causing a significant delay in the surgery.Surgery took place on (b)(6) 2016.

• Brand Name: MESA SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719195195
• MDR Report Key: 6425108
• MDR Text Key: 70596564
• Report Number: 3004774118-2017-00033
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 801-06545
• Device Lot Number: CVVX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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
• Patient Outcome(s): Other