FDA Adverse Event Malfunction Summary report: N

WAVE D SPINAL SYSTEM

MDR report key: 3881961 · Received June 18, 2014

Report

Report Number: 1030489-2014-02785
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: May 20, 2014
Report Date: June 24, 2014
Manufacturer: WARSAW ORTHOPEDIC, INC.
Product Code: MAX
PMA / PMN Number: K121333
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

Additional Manufacturer Narrative · 1

CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE LOCATION, ANGULATION AND DIRECTION OF THE FLANGE FRACTURES SUGGEST BEND STRESS OVERLOAD AS THE MECHANISM OF FAILURE. THIS IS LIKELY DUE TO ANGULATED INSERTION INTO INTERVERTEBRAL DISC SPACE DURING IMPACTION.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A ONE LEVEL PLIF WITH CAGE IMPLANTATION. WHILE INSERTING THE CAGE, IT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357585	WAVE D SPINAL SYSTEM	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR	MAX	WARSAW ORTHOPEDIC, INC.		0263822W

Patients

Seq	Age	Sex	Outcome	Treatment
1