| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GERZOG MALLET LEAD-FILL 1IN(2.5CM) HEAD | MALLET | KAPP SURGICAL GMBH | HXL | OS1512 | XKAZ05 AND XKAZ06 | R | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-19 | 0 |
Patient 1
(B)(4). ON 09JAN2017, WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT TRACKING NUMBER AND REQUESTED FOLLOW UP INFORMATION INCLUDING AS TO IF THERE WAS ANY PATIENT IMPACT RELATED TO THIS EVENT. WRITER PROVIDED CONTACT INFORMATION. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.
Patient 1
SALES REP REPORTED VIA EMAIL: METAL IS FLAKING WHILE USING TO PUT IMPLANTS IN, TAPPING THE IMPLANT APPLICATOR IN. PATIENT IMPACT UNKNOWN. ON 10JAN2017 ADDITIONAL INFORMATION: WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? ANTERIOR CERVICAL MICRODISCECTOMY AND FUSION. THE MALLET IS USED TO GENTLY TAP IN THE INTERBODY CAGE. THE CAGE IS PLACED ON A SLENDER METAL INSERTER WHICH HOLDS THE CAGE IN PLACE WHILE THE SURGEON GENTLY TAPS ON THE END OF THE INSERTER. THIS IS DONE UNDER AN OPERATING MICROSCOPE AS THIS IS A VERY DELICATE PROCEDURE PLACING THE CAGE JUST SLIGHTLY ABOVE THE SPINAL CORD. THEREFORE THERE IS NO EXCESSIVE FORCE BEING USED TO PLACE THE CAGE. DID ANY PART THE INSTRUMENT FALL INTO THE PATIENT?S BODY, AND IF SO HOW WAS IT RETRIEVED? NOTHING FELL INTO THE BODY THAT WE COULD OBSERVE WHILE UNDER THE MICROSCOPE. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT?S BODY, SUCH AS AN X-RAY? YES, WE ALWAYS TAKE A POST-SURGICAL X-RAY TO DETERMINE THE CORRECT SURGICAL LEVEL AND PLACEMENT OF THE IMPLANTS. WHAT WAS THE PATIENT?S OUTCOME? NO UNTOWARD OUTCOME NOTED. WAS THE PROCEDURE COMPLETED AS PLANNED? YES. CAN YOU PLEASE SEND ALL PARTS OF THE INSTRUMENT FOR EVALUATION? YES. LOT NUMBERS: XKAZ05 AND XKAZ06.
Patient 1
(B)(4). THE SAMPLE WAS PROVIDED AND AN EVALUATION WAS PERFORMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS DUE TO IMPROPER USE. THE PRODUCT EXHIBITS SEVERE DEFORMITIES. IT CAN BE CONCLUDED FROM THIS THAT THE HAMMER WAS USED WITH GREAT FORCE EXPENDITURE. IT IS KNOWN THAT LEAD IS A SOFT MATERIAL WHICH THEN DEFORMS CORRESPONDINGLY DEPENDING ON THE FORCE EXPENDITURE. THE PRODUCT HAS BEEN MANUFACTURED AND TESTED ACCORDING TO SPECIFICATIONS. THERE HAVE BEEN NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) DID NOT IDENTIFY AND ISSUES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.