FDA Adverse Event Malfunction Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 2060270 · Received April 15, 2011

Report

Report Number: 1030489-2011-00433
Event Type: Malfunction
Date Received: April 15, 2011
Date of Event: March 28, 2011
Report Date: March 28, 2011
Manufacturer: WARSAW ORTHOPEDIC, INC.
Product Code: KWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED LOT 0136245W, EXPIRATION DATE 01/08/2019; LOT 0136380W, EXPIRATION DATE 01/18/2019. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG 7640020, 510K # K052187 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0136245W IS 01/25/2011; THE MANUFACTURE DATE FOR LOT 0136380W IS 01/24/2011. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION INSTRUMENTATION AT T4-L3. DURING THE PROCEDURE, THE PEDICLE SCREW, SET SCREW, AND THE ROD WERE NOT ANCHORED PROPERLY. THE ROD HAD MOBILITY AFTER THE SET SCREW WAS BROKEN OFF AND IMPLANTED. NO PATIENT COMPLICATIONS OR OTHER COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CD HORIZON SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDIC, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	00015 YR