2530088-2013-01183

Report

Report Number: 2530088-2013-01183
Event Type: Malfunction
Date Received: September 26, 2013
Date of Event: December 4, 2011
Report Date: September 13, 2013
Manufacturer: SYNTHES BRANDYWINE
Product Code: MJO
PMA / PMN Number: P050010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. PLACEHOLDER.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE VERTEBRAL BODY FRACTURES RELATED TO THE MULTI-LEVEL IMPLANTATION OF THE PRODISC-L LISTED IN THIS ARTICLE HAVE ALREADY BEEN REPORTED PREVIOUSLY AS COMPLAINTS BY THE MAIN AUTHOR, HUMBERT (DREW) SULLIVAN. COMPLAINT FILES WERE ALSO PREVIOUSLY OPENED FOR THE CHISELS USED DURING THESE CASES, WHICH WERE RETURNED FOR EVALUATION BY PRODUCT DEVELOPMENT. AS LISTED IN THE PRODUCT DEVELOPMENT EVALUATIONS FOR THOSE COMPLAINTS, THE COMPLAINTS WERE DEEMED INDETERMINATE FROM A DESIGN PERSPECTIVE. NO NEW INFORMATION HAS BEEN PRESENTED IN THIS ARTICLE THAT WOULD CHANGE THE DISPOSITION OF THE COMPLAINTS. SINCE EACH OF THE VERTEBRAL BODY FRACTURES HAVE ALREADY BEEN PREVIOUSLY DOCUMENTED AND TRACKED AS COMPLAINTS, NO CHANGES TO THE OCCURRENCE RATE FOR THIS FAILURE MODE HAVE BEEN INTRODUCED FROM THIS JOURNAL ARTICLE. THE DESIGN & CLINICAL RISK ASSESSMENT REMAINS APPROPRIATE AND ADEQUATELY ADDRESSES THE COMPLAINT EVENTS PRESENTED IN THE JOURNAL ARTICLE. THE COMPLAINTS REMAIN INDETERMINATE.

Description of Event or Problem · 1

JOURNAL ARTICLE RECEIVED: PREVENTION OF VERTEBRAL BODY-SPLITTING FRACTURES AFTER MULTILEVEL PRODISC-L IMPLANTATION, SULLIVAN H.G., BERTAGNOLI R., NIGOGOSYAN M.A., LADWIG N.R., BORN H.L., CERNIGLIA M.M., HABBICHT H., MATHIASON M.A., MCHUGH V.L. INTERNATIONAL JOURNAL OF SPINE SURGERY. 6 (1)(PP 93-102), 2012; REPORTED: TWO GROUPS OF PATIENTS, ONE GROUP IN THE UNITED STATES AND ONE GROUP IN GERMANY, WHO RECEIVED MULTILEVEL PD-L IMPLANTS UTILIZING THE STANDARD US TECHNIQUE IN THE 1ST GROUP AND A MODIFICATION OF THE US TECHNIQUE CONSISTING OF A COMBINATION OF STRESS-RELIEVING PILOT HOLES, REMOVAL OF CORTEX IN THE CHISEL PATH, AND A FENESTRATED CHISEL (PH/CR/FC) IN THE 2ND GROUP, WERE EVALUATED FOR THE PRESENCE OF VERTEBRAL BODY ¿ SPLITTING FRACTURES (VB-SFS) VIA POSTOPERATIVE CT SCANS. A RETROSPECTIVE REVIEW OF MEDICAL RECORDS INVOLVING 1 MALE AND 4 FEMALES IN THE 1ST GROUP WITH A MEAN AGE OF 42.8 (33 TO 62) WHO RECEIVED MULTILEVEL PD-L IMPLANTS BETWEEN LEVELS L3 AND S1 FROM JULY 1, 2008 TO MARCH 3, 2009 WERE COMPARED TO THE MEDICAL RECORDS OF 6 MALES AND 5 FEMALES IN THE 2ND GROUP WITH A MEAN AGE OF 43.3 (27 TO 53) WHO RECEIVED MULTILEVEL PD-L IMPLANTS FROM AUGUST 4, 2009 TO JULY 9, 2010. FIVE FRACTURES (4 VB-SFS AND 1 ANTERIOR KEEL CUT-TO-ANTERIOR KEEL CUT FRACTURE) WERE IDENTIFIED ON POSTOPERATIVE CT SCANS IN THE 1ST GROUP. FOUR PATIENTS WERE ASYMPTOMATIC AND THE 5TH PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT 10 DAYS POST-OP CAUSING HIS PAIN. THERE WERE NO FRACTURES NOTED IN THE 13 PATIENTS FROM THE 2ND GROUP. IT WAS NOTED THAT AN ADDITIONAL PATIENT, WITH TRANSITIONAL 3-LEVELS, WAS OPERATED ON USING THE PILOT HOLES ONLY (PHO) TECHNIQUE AND EXPERIENCED VB-SF IN 1 INTERPOSED VERTEBRAL BODY AND NO FRACTURES IN THE OTHER INTERPOSED VERTEBRAL BODIES. A CENTRAL VERTICAL COLUMN OF BONY SCLEROSIS WAS NOTED ON FOLLOW-UP CT SCANS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS 2 OF 3 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
488371			MJO	SYNTHES BRANDYWINE

Patients

Seq	Age	Sex	Outcome	Treatment
1