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

Model Number N/A

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 06/03/2020

Event Type  Injury  

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 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.

• Brand Name: SPF-PLUS 60/M
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: sara dailey ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 10211521
• MDR Text Key: 201189368
• Report Number: 0002242816-2020-00072
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2020

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
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention