MAUDE Adverse Event Report: EBI, LLC. SPF-XL IIB 2/DM; STIMULATOR, INVASIVE, BONE GROWTH

Model Number N/A

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that there was a malfunction of the spf-xl iib 2/dm which resulted in an explant of the device.It was reported that the lead of the spf device was unplugged.The device was explanted and a replacement spf was implanted.Attempts have been made and no further information has been provided.

Event Description

It was reported that there was a malfunction of the spf-xl iib 2/dm which resulted in an explant of the device.It was reported that the lead of the spf device was unplugged.The device was explanted and a replacement spf was implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The device was not returned to zimmer biomet 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.Zimmer biomet will continue to monitor for trends.The following sections have been updated: b4: date of this report added.D4: additional device information added.E1: initial reporter address information added.G4: date received by manufacturer added.G7: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: method code updated to 3331: analysis of production records.H6: method code updated to 4114: device not returned.H6: results code updated to 3221: no findings available.H6: conclusions code updated to 4315: cause not established.H10: additional narratives / data.The following section has been corrected: e1: initial reporter establishment name corrected.

• Brand Name: SPF-XL IIB 2/DM
• Type of Device: STIMULATOR, INVASIVE, BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 10038520
• MDR Text Key: 190341987
• Report Number: 0002242816-2020-00044
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 00812301020089
• UDI-Public: 00812301020089
• Combination Product (y/n): N
• PMA/PMN Number: P850035/S023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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: Health Professional
• Device Expiration Date: 07/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention