FDA Adverse Event Injury Summary report: N

REFORM 6.5 X 45MM POLYAXIAL PEDICLE SCREW

MDR report key: 4634922 · Received March 24, 2015

Report

Report Number: 3005739886-2015-00036
Event Type: Injury
Date Received: March 24, 2015
Date of Event: December 18, 2014
Report Date: March 2, 2015
Manufacturer: PRECISON SPINE, INC
Product Code: MNH
PMA / PMN Number: K121172
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ENGINEERING EVALUATION OF THE RETURNED SCREW CANNOT DUPLICATE THE CLAIM THAT THE POLYAXIAL DRIVER WOULD NOT UNTHREAD FROM THE TULIP OF THE SCREW; THERE IS NO EVIDENCE OF THIS ISSUE PRESENT IN THE RETURNED COMPONENTS. IN REGARDS TO THE NECK SHEARING ON THE SCREW THERE IS NOT ENOUGH INFORMATION TO SUGGEST THERE ARE ANY DESIGN OR MANUFACTURING ISSUES PRESENT; IT IS NOT KNOWN HOW THIS EXACTLY OCCURRED, BUT THAT IT WAS OUTSIDE OF THE PATIENT UNDER ABNORMAL CONDITIONS. REVIEW OF MANUFACTURING RECORDS FOUND A TOTAL OF (B)(4) PIECES OF THIS LOT WERE RELEASED FOR DISTRIBUTION IN MARCH OF 2013. A 2-YEAR COMPLAINT HISTORY REVIEW FOUND THIS TO BE THE FIRST REPORT OF INSTRUMENT STICKING IN THE HEAD OF THE SCREW. THIS REPORT IS #3 OF 3 MDR'S FILED FOR THE SAME EVENT (REF#30057398896-2015-00034/36).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A L3-S1 PROCEDURE PERFORMED ON (B)(6) 2014, WHILE SEATING THE 6.5 X 45M REFORM POLYAXIAL SCREW ((B)(4)), THE SCREWDRIVER GOT STUCK IN THE HEAD OF THE SCREW AND THE SCREW HAD TO BE REMOVED FROM THE PATIENT. UPON DISASSEMBLY OF THE DRIVER FROM THE SCREW (OUTSIDE OF THE PATIENT) THE HEAD OF THE SCREW BROKE OFF OF THE SHAFT. NO DELAY TO THE PROCEDURE RESULTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
198072	REFORM 6.5 X 45MM POLYAXIAL PEDICLE SCREW	MNH, MNI	MNH	PRECISON SPINE, INC		0198BG

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention