FDA Adverse Event Malfunction Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 3781483 · Received April 30, 2014

Report

Report Number: 1030489-2014-02354
Event Type: Malfunction
Date Received: April 30, 2014
Date of Event: April 2, 2014
Report Date: April 2, 2014
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NKB
PMA / PMN Number: K122862
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITONAL INFO: VISUAL ANALYSIS REVEALS THAT THERE ARE SOME WITNESS MARKS ON THE TABS OF THE INSERTERS INDICATING THAT FORCE WAS APPLIED TO THEM. DURING A FUNCTIONAL TEST THE EXTENDERS HOOKED ON TO A SAMPLE SCREW AND COULD NOT BE PULLED FREE IF LOCKED IN PROPERLY. IF THE EXTENDER IS NOT LOCKED DOWN PROPERLY THE EXTENDER WILL POP LOOSE. NO ROOT CAUSE DETERMINED THE FAILURE COULD NOT BE REPLICATED. THE QUALITY TECHNICIAN WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. WITH THE AVAILABLE INFORMATION ABOUT THE FIELD EXPERIENCE, A CAUSE OR CONTRIBUTING FACTOR TO CANNOT BE IDENTIFIED.

Additional Manufacturer Narrative · 1

(B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT T11-L4 TO TREAT INFECTIOUS SPONDYLITIS AT L1 AND L2. IT WAS REPORTED THAT THE EXTENDER HAD DISENGAGED FROM THE SCREW HEAD. THE SURGERY TIME WAS EXTENDED LESS THAN 15 MIN. NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
260208	CD HORIZON SPINAL SYSTEM	ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	NKB	MEDTRONIC SOFAMOR DANEK USA, INC	NA	EM13C008

Patients

Seq	Age	Sex	Outcome	Treatment
1