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

Catalog Number 6201-05535

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 was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.Since the screw remains in the patient no physical, material, chemical evaluation could be performed.If more information becomes available manufacturer will file a follow-up report at that time.

Event Description

It was reported to k2m, inc.On 05.10.2016 that two polyaxial screws were only able to be partially locked intra-op.

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 no lot number has been identified/confirmed in this case.Since the screw remains in the patient no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.Although no definitive root cause could be ascertained, damage to the lips of the outer collet due to instrument misalignment can cause the screw to become difficult to lock.

Event Description

It was reported to k2m, inc.On (b)(6) 2016 that two polyaxial screws were only able to be partialy locked intra-op.

• 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: 5698003
• MDR Text Key: 46513971
• Report Number: 3004774118-2016-00035
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857163751
• UDI-Public: 10888857163751
• 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: 6201-05535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2016
• 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