FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 2920616 · Received January 17, 2013

Report

Report Number: 1030489-2013-00163
Event Type: Injury
Date Received: January 17, 2013
Report Date: February 11, 2013
Manufacturer: WARSAW ORTHOPEDIC, INC.
Product Code: NKB
PMA / PMN Number: K052187
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. HOWEVER, X-RAY IMAGES SHOW AP <(>&<)> LATERAL VIEWS OF COMPLEX CONSTRUCT FROM L5 TO ABOVE T12. LEFT L5 PEDICLE SCREW IS SEPARATED FROM ROD DUE TO SET SCREW DISLODGEMENT.

Additional Manufacturer Narrative · 1

ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO PRE-EXISTING DEFECT WAS FOUND ON THE RETURNED IMPLANTS WHICH COULD BE RESPONSIBLE OF THE EVENT. THE LOOSENING OF THE SETSCREWS MAY COME FROM: - OVER TIGHTENING OF THE SETSCREWS AFTER THEIR BREAK OFF LEADING TO THE SPLAY OF THE BONE SCREW TULIP - IMPROPER INSERTION OF THE ROD INTO THE ROD CANAL OF THE PEDICLE SCREW: IN SUCH CONDITION, WHEN THE PATIENT STANDS UP, REALIGNMENT OF THE ROD INTO THE ROD CANAL MAY HAPPEN INDUCING SETSCREW LOOSENING.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE WITH HARDWARE IMPLANTATION. AT AN UNKNOWN TIME POST-OPERATIVELY, IT WAS DISCOVERED THAT "THE REDUCTION SETSCREWS HAD DISENGAGED FROM THE END OF THE CONSTRUCT". A REVISION SURGERY WAS DONE TO REMOVE THE MIGRATED SCREWS. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26339	CD HORIZON SPINAL SYSTEM	ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	NKB	WARSAW ORTHOPEDIC, INC.		0183383W

Patients

Seq	Age	Sex	Outcome	Treatment
1	00024 YR		Other\| R