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

Catalog Number 6201-35035

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product has not yet been returned to manufacturer for evaluation, and a thorough investigation could not be completed at this time.When more information becomes available manufacturer will file a follow-up report.Not received.

Event Description

It was reported to k2m, inc on (b)(6) 2016 that a uniplanar screw was unable to be fully locked intra-op and was replaced at that time.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, storage and distribution records according to the description of the product used was conducted.All records revealed that the product lot was manufactured within specifications and distributed in accordance with all operating procedures.A review of the manufacturing and inspection records did not reveal any contributing information/trends.The damage to the lips of the outer collet of the returned screw is consistent with instrument misalignment.Once the lips are compromised, it becomes difficult to lock the screw.This likely happened to the screws that remain in the patient, although no definitive root cause can be determined.

Event Description

It was reported to k2m, inc on (b)(6) 2016 that a uniplanar screw was unable to be fully locked intra-op and was replaced at that 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 ; 5719192000
• MDR Report Key: 5697965
• MDR Text Key: 46514200
• Report Number: 3004774118-2016-00034
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 6201-35035
• Device Lot Number: DWWU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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: 6201-05535 LOTS UNKNOWN