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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem No Information (3190)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If implanted, give date: the product was implanted in 2012; specific date is unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient complained about the stimulator, therefore a revision was performed due to the patient's weight loss which caused the bone stimulator battery to migrate.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.No failure condition was found and/or identified after the investigation associated with revision due to migration of the bone stimulator generator due to weight loss.A review of the affected device confirmed it was nonoperational as expected/intended because the device was implanted in 2012; therefore, the device has since long exceeded its therapeutic treatment and operational life of twenty-four (24) weeks and therefore is not functional in accordance with the spf physician manual & info 1067632l revision f.A review of the analytical laboratory records for sterilization batch 539-12, concluded that all tests performed passed.Device history record (dhr) was reviewed and no discrepancies were found.The complaint was not confirmed.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.(b)(4).

Event Description

It was reported the patient complained about the stimulator, therefore a revision was performed due to the patient's weight loss which caused the bone stimulator battery to migrate.No additional patient consequences were reported.

• 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: 7182882
• MDR Text Key: 96991979
• Report Number: 0002242816-2018-00002
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/26/2014
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 03/31/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR