ZIMMER BIOMET COMPLAINT (B)(4). DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2020. MEDICAL PRODUCT: SPINALPAK ASSEMBLY CATALOG: #1066716 SERIAL: # (B)(4). THERAPY DATE: UNKNOWN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002242816-2020-00011. THE DEVICE HAS NOT BEEN RETURNED.
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Patient 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION FROM USING THE 63B ELECTRODES AND THE COVER PATCHES ON HIS LOWER BACK. THE PATIENT STATED THAT HE DID NOT HAVE ANY PAIN, THE SKIN WAS JUST VERY ITCHY. THE SKIN BECAME VERY RAW AND WOULD BLEED. THE PATIENT DID CONTACT HIS DOCTOR WHO ADVISED THE PATIENT TO DISCONTINUE USE OF THE UNIT. THE PATIENT REPORTED THAT SINCE HE STOPPED USING THE DEVICE ALL THAT HE HAS LEFT IS A LITTLE BIT OF A SCAB. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.