FDA Adverse Event Injury Summary report: N

X-STOP IPD SYSTEM

MDR report key: 1577913 · Received December 31, 2009

Report

Report Number: 2953769-2009-00212
Event Type: Injury
Date Received: December 31, 2009
Report Date: January 31, 2008
Manufacturer: MEDTRONIC SPINE LLC
Product Code: NQO
PMA / PMN Number: P040001
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REFERENCE: MDR 2953769-2008-00027, 00028, 00029, AND 00030. REPORT SOURCE: ARTICLE TITLED "A RETROSPECTIVE ANALYSIS OF PATIENT OUTCOMES WITH X-STOP INTERSPINOUS PROCESS DECOMPRESSION IMPLANT FROM A REGIONAL ORTHOPEDIC SPINE CENTER' BY WALTER O. CARLSON, MD; GAIL M. BENSON, MD; MITCHELL C. JOHNSON, DO; MATTHEW J. MCKENZIE, MD; AARON BABB, BA; DARIN VANDERWELL, BA. DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW-UP WITH AUTHOR.

Description of Event or Problem · 1

IN AN ARTICLE TITLED "A RETROSPECTIVE ANALYSIS OF PATIENT OUTCOMES WITH X-STOP INTERSPINOUS PROCESS DECOMPRESSION IMPLANT FROM A REGIONAL ORTHOPEDIC SPINE CENTER", THE FOLLOWING EVENTS WERE REPORTED: X-STOP REMOVAL DUE TO TREATMENT FAILURE (4 PATIENTS): ONE PATIENT: THE X-STOP DID NOT HELP THE PATIENT'S BILATERAL LEG PAIN DUE TO LUMBAR SPINAL STENOSIS AND SHE WANTED FURTHER TREATMENT. ONE PATIENT: EXPERIENCED PAIN IN BOTH LEGS AND TROUBLE WITH AMBULATION, WHICH WAS NOT ALLEVIATED BY X-STOP; LEADING TO X-STOP REMOVAL AND A DECOMPRESSION LAMINECTOMY. ONE PATIENT: THE DEVICE FAILED TO ALLEVIATE SYMPTOMS AND WAS THEREFORE REMOVED SO A DECOMPRESSIVE LAMINECTOMY COULD BE PERFORMED. ONE PATIENT: X-STOP REMOVAL. NO FURTHER INFORMATION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	X-STOP IPD SYSTEM	INTERSPINOUS PROCESS SPACER	NQO	MEDTRONIC SPINE LLC	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other