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

Catalog Number 3001-84545

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation as it remains in the patient's body.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(4) 2017 it was reported to k2m, inc.That a failed connector was discovered post-operatively.Revision surgery was performed on (b)(6) 2017.

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 rod connector remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.The set screws used in the index surgery were discarded and replaced.Attempts to recreate the incident indicate that if the set screws are fully tightened when the rods are not parallel to one another, it is possible to generate a point contact between the set screw and the rod.This could have contributed to decreased axial rigidity thus leading to rod slippage.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a failed rod connector was discovered post-operatively.Revision surgery was performed on (b)(6) 2017 in which additional connectors were added to each side of the construct.

• Brand Name: MESA SM STATURE 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: 7028384
• MDR Text Key: 91935529
• Report Number: 3004774118-2017-00185
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 3001-84545
• Device Lot Number: FPMH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• 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): Required Intervention