MAUDE Adverse Event Report: EBI, LLC. OSTEOGEN-40/M; STIMULATOR, INVASIVE BONE GROWTH

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: manufacturer: (b)(4), implant names: vitose bb.Trauma bone graft, modeucat no: 2102-2210, lot no: b1610024; vitoss bb trauma bone graft, modeucat no: 2102-2205.Lot no: b1610018; 7.0 x 90 headless cannulated screw.Modeucat no: 658390 (1); 5.0 x 50 headless screw.Model/cat no: 658150 (2): 4.0 x 60 cannulated screw, modeucat no: 604660 (1); 4.0 x 55 cannulated screw, modeucat no: 604655 (1).Therapy date: (b)(6) 2018.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.Mw5075759.

Event Description

Report number mw5075759 was received which states "patient, original ankle surgery (b)(6) 2017 with a zimmer bone stimulator implanted with additional implants.Reportedly patient has had problems with his ankle after the surgery on (b)(6) 2017, and was scheduled for revision surgery on (b)(6) 2017.Subsequently, physician received a recall letter related to the zimmer bone stimulator item# 10-1348m, lot# 521203.Item description: ogen dual mesh cathodes." no additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No x-rays, scans, pictures, or physician's reports were provided and no product was returned for evaluation.Device history record (dhr) was reviewed and no discrepancies 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).

• Brand Name: OSTEOGEN-40/M
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 7624822
• MDR Text Key: 111863664
• Report Number: 0002242816-2018-00021
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

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: 06/24/2017
• Device Model Number: N/A
• Device Catalogue Number: 10-1348M
• Device Lot Number: 521203
• Other Device ID Number: (01) 0 0812301 02010 2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention