FDA.reportPublic FDA data

MAUDE MDR 3009929

MDR report key
3009929
Report number
8030965-2013-10515
Event key
0
Event type
3
Date of event
2012-01-31
Date received
2013-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
T MCCARRON
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
800-800-8006
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MIDLINE MARKER 8MM WIDTH 250MMSYNTHES GMBHEMLPDL120T935463R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-180

Event Narratives#

D

Patient 1

THIS REPORT IS FOR FILE (B)(4).

N

Patient 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE DEVICE DESIGN FOR THE POLY REMOVAL TOOL, ENDPLATE HOLDING ARM, AND MIDLINE MARKER WERE REVIEWED AND FOUND TO BE APPROPRIATE FOR THEIR INTENDED USE. IT SHOULD BE NOTED THAT THE DEVICES WERE NOT RETURNED FOR EVALUATION, SO THE EXACT FAILURE MODE CANNOT BE DETERMINED FOR EACH INSTRUMENT. THE IMPLANTS REMOVED IN THIS CASE WERE ALSO NOT RETURNED, SO NO ATTEMPTS CAN BE MADE TO EVALUATE ANY MATCHING DEFORMATION TO PREDICT HOW THESE INSTRUMENTS MAY HAVE BEEN USED. ANTERIOR LUMBAR REVISION SURGERIES ARE EXTREMELY DEMANDING, ESPECIALLY IN OBTAINING THE NECESSARY ACCESS EXPOSURE AS THE ORIGINAL EXPOSURE HAS BEEN AFFECTED BY SCAR TISSUE. IN ADDITION, THIS REVISION CASE WAS REPORTED TO INVOLVE A SUBSIDED IMPLANT, WHICH MAY HAVE ALSO PRESENTED INSTRUMENT/IMPLANT ALIGNMENT CHALLENGES DEPENDING ON THE ORIENTATION OF THE SUBSIDED IMPLANT. IF THE ACCESS ANGLE TO THE SPINE DOES NOT ALLOW DIRECT VISUALIZATION OF THE DISC SPACE, OR THE IMPLANT ORIENTATION IS CHALLENGING, EXCESSIVE BENDING MOMENTS MAY BE APPLIED TO THE INSTRUMENTS. THESE APPLIED MOMENTS COULD CAUSE THE PIN ON THE ENDPLATE HOLDING ARM TO BEND AND EVENTUALLY BREAK, OR RESULT IN BENDING OR BREAKING OF THE REMOVAL TOOL TEETH OR MIDLINE MARKER TIP WHEN LEVERAGED AGAINST BONE OR ANOTHER METALLIC SURFACE (ENDPLATES). IN ADDITION, IF THE ENDPLATE HOLDING ARM IS USED SOLELY TO LIBERATE THE SUPERIOR IMPLANT ENDPLATE FROM THE VERTEBRAL BODY, THE PINS CAN BEND OR BREAK UNDER THE APPLICATION OF SIGNIFICANT MOMENT ARM. THE TECHNIQUE GUIDE WARNS AGAINST THIS TYPE OF LEVERAGING WITH THIS INSTRUMENT. SINCE THE INSTRUMENTS WERE NOT RETURNED FOR EVALUATION, AND THE EXACT FAILURE MODE CANNOT BE DETERMINED IN THIS CASE, POSSIBLE CAUSES OF THE DESCRIBED FAILURE MAY BE FROM EXCESSIVE APPLIED BENDING MOMENTS AS A RESULT OF DIFFICULT ACCESS EXPOSURE ALIGNMENT TYPICAL OF ANTERIOR LUMBAR REVISION CASES. THEREFORE, THE COMPLAINT IS DEEMED INDETERMINATE.

N

Patient 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

N

Patient 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. NO SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

D

Patient 1

IT WAS REPORTED THAT DURING A PDL REMOVAL ON (B)(6) 2012, THE SURGEON USED THE SLAP HAMMER TO REMOVE THE HOLDING ARM (WHICH WAS USED TO REMOVE THE INFERIOR ENDPLATE) AND THE TAB BROKE OFF OF THE HOLDING ARM. THE BROKEN TAB WAS RETRIEVED. THE TIP OF THE MIDLINE MARKER BROKE OFF WHILE TRYING TO DISLODGE THE POLY INLAY FROM THE INFERIOR ENDPLATE. THE BROKEN TIP WAS RETRIEVED. SURGEON WAS ABLE TO REMOVE POLY INLAY WITH SAME DEVICE. THE TEETH BROKE OFF OF THE POLY INLAY REMOVER WHILE TRYING TO ENGAGE THE POLY INLAY FOR REMOVAL. THE BROKEN TEETH WERE RETRIEVED. SURGEON USED A DIFFERENT DEVICE TO REMOVE THE INLAY. THE PATIENT WAS NOT HARMED. ALL THREE INSTRUMENTS ARE AVAILABLE FOR RETURN. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.