FDA Adverse Event Injury Summary report: N

X-STOP INTERSPINOUS SPACER SYSTEM

MDR report key: 2961550 · Received February 14, 2013

Report

Report Number: 1030489-2013-00475
Event Type: Injury
Date Received: February 14, 2013
Report Date: January 10, 2013
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: NQO
PMA / PMN Number: P040001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

LITERATURE CITATION: MAGAN NIELSEN. "X-STOP SURGICAL IMPLANT FOR THE TREATMENT OF LUMBAR SPINAL STENOSIS: CLINICAL PRACTICE RECOMMENDATIONS FOR NEUROSURGICAL NURSE PRACTITIONERS." JOURNAL OF NEUROSCIENCE NURSING 2013; VOLUME 45, NUMBER 1, PAGES 44-51. DATE OF EVENT IS UNKNOWN. (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

AN ARTICLE DESCRIBES THE USE OF A NEWER, LESS-INVASIVE SURGICAL TECHNIQUE VIA AN INTERSPINOUS SPACER SYSTEM TO TREAT NEUROGENIC INTERMITTENT CLAUDICATION (NIC) BECAUSE OF LUMBAR SPINAL STENOSIS PROVIDES CLINICAL PRACTICE RECOMMENDATIONS FOR NEUROSURGICAL NURSE PRACTITIONERS. IT WAS REPORTED IN THIS ARTICLE THAT ONE YEAR POST-OP, TWO PATIENTS OUT OF 24 HAD NIC SYMPTOMS RETURN BECAUSE OF "IMPLANT SLIP". BOTH PATIENTS UNDERWENT IMPLANT REMOVAL FOLLOWED BY DECOMPRESSIVE LAMINECTOMY AND FUSION. NO FURTHER INFORMATION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
65060	X-STOP INTERSPINOUS SPACER SYSTEM	PROSTHESIS, SPINOUS PROCESS SPACER/PLATE	NQO	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention