MAUDE Adverse Event Report: EBI, LLC. SPF PLUS-MINI (60 ¿A/M); SPF-PLUS 60/M, SPINAL FUSION STIMULATOR

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
It was reported by the sales rep that approximately 2 weeks after undergoing surgery for cervical fusion and having an spf bone stimulator implanted, the patient¿s surgeon stated that she had an infection, at her follow up appointment.The surgeon was aware of a previous recall involving the spf product and was concerned that the device might have caused the infection.The surgeon scheduled the patient for surgery a day later to explant the device.Following the surgery, the sales rep further reported that there was no bacterial infection, and the physician seems to believe that the patient had a reaction to the stimulator.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Complaint sample was evaluated and the reported event was not confirmed.Review of operative notes did not confirm the complaint.Reported condition was not verifiable after the investigation associated with infection.Further review of the manufacturing process and sterilization process found the final cleaning of the unit was performed on march 7, 2019.The bioburden reduction control was performed on march 8, 2019 and sterilized on march 11, 2019.The unit expiration date was january 24, 2021.The implantable dhr indicates that product meets the zimmer biomet specification and no abnormal condition was reported.No abnormal condition could be identified during the investigation and device evaluation that could be considered causal factor for the reported condition.Dhr was reviewed and no discrepancies relevant to the reported event were found.The device analysis indicated that the device met specification.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Updated: b4- date of this report added.D4- serial no.Added.E1- reporter address and fax number added.G3- report source added.G4- date received by manufacturer added.G7- type of report added.H2- type of follow-up added.H3- device evaluated by manufacturer added.H4- device manufacturer date added.H6 method code updated to 10-testing of actual/ suspected device.H6 method code updated to 3331- analysis of production records.H6 results code updated to 213- no device problem found.H6 conclusions code updated to 4310- cause cannot be traced to device.Corrected: e1- reporter name and phone number corrected.E2- health professional corrected.E3- occupation corrected.
Event or Problem Description
It was reported by the sales rep that approximately 2 weeks after undergoing surgery for cervical fusion and having an spf bone stimulator implanted, the patient¿s surgeon stated that she had an infection, at her follow up appointment.The surgeon was aware of a previous recall involving the spf product and was concerned that the device might have caused the infection.The surgeon scheduled the patient for surgery a day later to explant the device.Following the surgery, the sales rep further reported that there was no bacterial infection, and the physician seems to believe that the patient had a reaction to the stimulator.No additional patient consequences were reported.

• Brand Name: SPF PLUS-MINI (60 ¿A/M)
• Common Device Name: SPF-PLUS 60/M, SPINAL FUSION STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 8705747
• Report Number: 0002242816-2019-00018
• Device Sequence Number: 2073454
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P850035/S033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDICAL PRODUCT: ASTURA BRIDALVEIL SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention