FDA Adverse Event Other Summary report: N

BAXANO IO-FLEX SYSTEM

MDR report key: 2651996 · Received July 2, 2012

Report

Report Number: 3006324586-2012-00009
Event Type: Other
Date Received: July 2, 2012
Date of Event: February 10, 2011
Report Date: July 2, 2012
Manufacturer: BAXANO, INC.
Product Code: HAE
PMA / PMN Number: K100958
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IO-FLEX SYSTEM PRODUCT INFO & 510 (K) # (BRAND NAME, COMMON NAME, MODEL-CATALOG NO., LOT NO., MFG DATE/EXPIRY DATE): K100958 RONGEUR, MANUAL, BAXANO IO-FLEX PROBE, MODEL-CATALOG NO. IO-CP45, LOT 10120905, (12/20/2010 / 2012-12). K110696 SURGICAL NERVE STIMULATOR/LOCATOR, BAXANO IO-FLEX NEURO CHECK, MODEL-CATALOG NO. IO-NCW, LOT 10120901, (12/20/2010 / 2012-12). K113533 SURGICAL NERVE STIMULATOR/LOCATOR, BAXANO IO-FLEX WIRE, MODEL-CATALOG NO. IO-NCW, LOT 10120901, (12/20/2010 / 2012-12). K100958 RONGEUR, MANUAL, BAXANO IO-FLEX DISTAL HANDLE, MODEL-CATALOG NO. IO-DH, LOT 10112301, (12/02/2010 / 2012-11). K100958 RONGEUR, MANUAL, BAXANO IO-FLEX MICROBLADE SHAVER, MODEL-CATALOG NO. IO-MBS, LOT 10102103 (11/04/2010 / 2011-11).

Description of Event or Problem · 1

ON (B)(6) 2011, PT (B)(6) (MALE) UNDERWENT DECOMPRESSIVE SURGERY WITH BAXANO IO-FLEX TOOLS, OF THE LEFT L3/4 AND BILATERAL L4/5 DISC LEVEL PASS THROUGH LEFT L3/4 AND L4/5 LAMINECTOMY. THE PT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2011, (14 DAYS POST-SURGERY), THE PT PRESENTED WITH THE INCISION AREA THAT WAS SWOLLEN AND PAINFUL WITH MUSCLE SPASMS. AN INFECTION WAS DIAGNOSED, LANCED AND TREATED WITH LEVAQUIN AND RIFAMYCIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BAXANO IO-FLEX SYSTEM	RONGEUR, MANUAL, BAXANO IO-FLEX PROBE	HAE	BAXANO, INC.	IO-IP90	11010602

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR		Other