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

Catalog Number 801-08550D

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation as it remains in the patient.Investigation is still in process.Upon completion of the investigation, k2m inc.Will file a supplemental report indicating the findings.Remains in patient.

Event Description

On 09/08/2016 it was reported to k2m, inc.That during a surgery which took place on (b)(6) 2016 a mesa screw was left in the patient and was not fully locked to the rod.

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 was completed as the lot number has been identified/confirmed in this case.Since the screw remains in the patient, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.It was reported that multiple instruments could not engage and fully lock the screw.It is likely that the lips of outer collet became compromised at some point during the case.Once compromised it becomes difficult for instruments to fully engage onto the screw head.However, without the actual implant no definitive root cause can be determined.Our investigation and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.Remains in patient.

Event Description

On (b)(6) 2016 it was reported to k2m, inc.That during a surgery which took place on (b)(6) 2016 a mesa screw was left in the patient and was not fully locked to the rod.

• 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: 6001167
• MDR Text Key: 56542623
• Report Number: 3004774118-2016-00078
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 801-08550D
• Device Lot Number: DGEF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• 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