NKB, MNH, MNI

MDR report key: 5113889 · Received September 30, 2015

Report

Report Number: 2027467-2015-00182
Event Type: Malfunction
Date Received: September 30, 2015
Date of Event: July 30, 2015
Report Date: August 31, 2015
Manufacturer: ALPHATEC SPINE INC
Product Code: NKB
PMA / PMN Number: K123623
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TYPE OF REPORT - WAS MISTAKENLY MARKED AS A 5 DAY REPORT. CORRECTED INFORMATION NOW STATES INITIAL REPORT.

Additional Manufacturer Narrative · 1

AN EVALUATION OF THE FRACTURED ILLICO ROD IS NOT POSSIBLE AT THIS TIME. THE IDENTIFYING PART AND/OR LOT NUMBER HAVE NOT BEEN PROVIDED NOR HAS THE ROD BEEN REMOVED FROM THE PATIENT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION/DETAILS OF THE EVENT HAVE BEEN UNSUCCESSFUL. THE ILLICO MIS POSTERIOR FIXATION SYSTEM IS INTENDED TO FACILITATE THE SURGICAL CORRECTION OF NONCERVICAL SPINAL DEFORMITIES BY PROVIDING TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. WHEN USED FOR A MINIMALLY INVASIVE POSTERIOR APPROACH ILLICO MIS INSTRUMENTATION IS USED IN CONJUNCTION WITH POLYAXIAL SCREW COMPONENTS. THE IMPLANTS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (B)(4). THE RODS ARE AVAILABLE IN COMMERCIALLY PURE (CP) TITANIUM AND/OR COBALT CHROME.

Description of Event or Problem · 1

AN INTERNATIONAL CUSTOMER (B)(6) REPORTED THAT A PATIENT HAD GONE THROUGH AN ILLICO MIS SURGERY FROM L3-L5 ON (B)(6) 2014. ON AN X-RAY THAT WAS TAKEN ON THE (B)(6) 2015 THE ROD WAS DISCOVERED BROKEN. PATIENT IS COMPLAINING THAT HE HAS A LOT OF PAIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
645365		NKB, MNH, MNI	NKB	ALPHATEC SPINE INC

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 MO		Other