MAUDE Adverse Event Report: K2M, INC. KEYS MI ANTERIOR DEFORMITY SPINAL SYSTEM; ANTERIOR SPINAL SYSTEM

Catalog Number 4601-17035

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 08/29/2017

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.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b(6) 2017 it was reported to k2m, inc.That a rod slipped.Revision surgery took place (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 screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.It could not be confirmed if the subject screw was completely locked, as the devices were not returned for evaluation.It is possible that the rod pulled out of the screw due to overwhelming lever forces at the end of the construct.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a rod slipped.Revision surgery took place (b)(6) 2017.(related to 3004774118-2017-00173).

• Brand Name: KEYS MI ANTERIOR DEFORMITY SPINAL SYSTEM
• Type of Device: ANTERIOR 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: 6933507
• MDR Text Key: 89154061
• Report Number: 3004774118-2017-00172
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/25/2017

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: 4601-17035
• Device Lot Number: EPGR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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