MAUDE Adverse Event Report: EBI, LLC. SPF-PLUS 60/M; STIMULATOR, INVASIVE BONE GROWTH

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Material Discolored (1170)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision surgery for an spf-plus 60/m device.The surgeon reported that the spf unit appeared to be corroded.The surgeon later stated that the device had a rustic discoloration and was not corroded.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that the patient underwent a revision surgery for an spf-plus 60/m device.The surgeon reported that the spf unit appeared to be corroded.The surgeon later stated that the device had a rustic discoloration and was not corroded.No additional patient consequences/ further information has been reported.The spf-plus 60/m unit was not returned for further evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.(b)(6) medical will continue to monitor for trend.

• Brand Name: SPF-PLUS 60/M
• Common Device Name: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 10211521
• Report Number: 0002242816-2020-00072
• Device Sequence Number: 16677725
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P850035
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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?: Yes
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic