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

Catalog Number 6201-06535

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 05/22/2015

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the screws remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.The extension in the surgical time could be attributed to reopening the patient in order to reposition the misplaced screws.Upon further investigation it was determined that the incident was not product related.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a patient had to be reopened immediately after the surgery as two screws were determined to be outside the pedicle.Repositioning of the screws extended the overall surgical time.

• 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 ; 5719192195
• MDR Report Key: 7054017
• MDR Text Key: 92796157
• Report Number: 3004774118-2017-00188
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 6201-06535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 101-80013G LOT UNKNOWN; 101-A55500 LOT UNKNOWN; 6201-36540 LOT UNKNOWN; 801-15535 LOT UNKNOWN; 801-16535 LOT UNKNOWN; 801-16540 LOT UNKNOWN; 801-H55495T LOT UNKNWON
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR