MAUDE Adverse Event Report: EBI, LLC. EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR; STIMULATOR, INVASIVE BONE GROWTH

Model Number N/A

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient had an affected spf bone stimulator implanted and removed due to pain prior to the zfa 2018-00048 recall initiation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product 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 (dhr) review was unable to be performed as the serial number of the device involved in the event is unknown.The 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 were updated: b4: date of report added b5: event description updated.G1-2: name and email address updated.G4: date received by manufacturer added.G7: type of report.H2: follow-up type.H3: device evaluated by manufacturer updated to no.H6: patient code updated to 1994: pain.H6: device code updated to 3191: appropriate term/code not available.H6: method code updated to 4114: device not returned.H6: results code updated to 3221: no findings available.H6: conclusion code updated to 4315: cause not established.H10: additional narratives/data h3 other text : device has not been returned.

Event Description

It was reported the patient had an affected spf bone stimulator implanted and removed due to pain.Attempts have been made and no further information has been provided.No additional patient consequences have been reported.

• Brand Name: EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 7652978
• MDR Text Key: 112838826
• Report Number: 0002242816-2018-00023
• 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: 12/04/2019

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
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention