FDA Adverse Event Injury Summary report: N

X-STOP IPD SYSTEM

MDR report key: 2724737 · Received September 4, 2012

Report

Report Number: 2953769-2012-00125
Event Type: Injury
Date Received: September 4, 2012
Report Date: August 6, 2012
Manufacturer: MDT KYPHON SUNNYVALE MFG
Product Code: NQO
PMA / PMN Number: P040001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

LITERATURE ARTICLE CITATION: DAVID H. KIM ET AL. "ASSOCIATION BETWEEN DEGENERATIVE SPONDYLOLISTHESIS AND SPINOUS PROCESS FRACTURE AFTER INTERSPINOUS PROCESS SPACER SURGERY". THE SPINE JOURNAL 12 (2012); 466-472. DATE OF EVENT IS UNKNOWN. (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.

Description of Event or Problem · 1

IT WAS REPORTED IN A PROSPECTIVE (B)(6) STUDY THAT 38 PATIENTS UNDERWENT IPS (INTERSPINOUS PROCESS SPACER) SURGERY FOR LSS (LUMBAR SPINAL STENOSIS) WITH NEUROGENIC CLAUDICATION WITH A 1-YEAR FOLLOW-UP TIME PERIOD. IMPLANTS INCLUDED DEVICES COMPRISED OF TITANIUM OR PEEK FROM MULTIPLE MANUFACTURERS. IT WAS REPORTED THAT A MINIMALLY DISPLACED SPINOUS PROCESS FRACTURE DIRECTLY ADJACENT TO THE IMPLANT WAS IDENTIFIED BY CT (COMPUTED TOMOGRAPHY) IN A (B)(6) FEMALE PATIENT 2 MONTHS AFTER PLACEMENT OF AN INTERSPINOUS SPACER AT L4-L5. GRADE 1 DEGENERATIVE SPONDYLOLISTHESIS WAS ALSO OBSERVED AT THE SURGICAL LEVEL. NO FRACTURES WERE APPARENT ON THE LATERAL RADIOGRAPH TAKEN IMMEDIATELY BEFORE CT IMAGING FOR THIS PATIENT. NO FURTHER PATIENT INFORMATION OR COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	X-STOP IPD SYSTEM	PROSTHESIS, SPINOUS PROCESS SPACER/PLATE	NQO	MDT KYPHON SUNNYVALE MFG	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	00079 YR		Required Intervention