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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Swelling (2091)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (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.Device has not been returned.

Event Description

It was reported that the patient underwent a revision surgery approximately 2 months post implantation of the spf-xl iib 2/dm.Prior to the revision surgery, the patient developed swelling at the bone stimulator site.The patient had developed a suture abscess that resulted in a small opening of the surgical site, which began to drain.The bone stimulator was then explanted due to concern that the patient was having a reaction to the stimulator.During the removal, the wound was explored and the fluid around the device was drained.Two weeks after the revision surgery, the patient arrived at the emergency room with complaints of sharp lumbar pain, fever, chills, vomiting, decreased urination and retention, and dark urine.The patient underwent another surgical procedure to remove the necrotic and infected tissue from the lumbar spine.During the next five days, the patient received two blood transfusions and was under the care of an infectious disease specialist and other medical professionals.The patient continued antibiotic treatment, physical therapy, and occupational therapy.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was not returned to zimmer biomet for evaluation.The reported event was confirmed by review of medical records.The device history record (dhr) was reviewed and no discrepancies were found.The sterilization certificate indicates that the device was sterilized and met the certification requirements.The root cause was unable to be determined.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.D11: medical product: intervertebral titanium biomechanical device: 12mm at la-5 and 14mm at l5-s1.D11: medical product: trinity bone graft.D11: therapy date: april 6, 2017.The following sections were updated: a2: date of birth added.A3: patient sex added.A4: patient weight added.A5: patient ethnicity added.B4: date of this report added.B5: event description updated.B6: relevant test results added.B7: relevant history added.D4: expiration date.D11: concomitant medical products 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 h3 other text : the device was not returned.

Event Description

It was reported that the patient underwent a revision surgery two months post implantation of the spf-xl iib 2/dm.The patient underwent a revision of his lumbar fusion due to loosening of the pedicle screw with simultaneous implantation of the subcutaneous spinal stimulator.After surgery, the patient demonstrated improvement with pain and motion.At six weeks postop, a suture abscess was noted and treated with antibiotics.Due to the device recall and abscess, the patient underwent elective removal of the spinal stimulator.During the removal, no sign of infection was noted with deep exploration.The wound was irrigated and closed.(wound and device culture reports are included in section b7) the patient was subsequently readmitted for sepsis attributed to the lumbar wound.A second incision and drainage was performed, and the patient was treated by an infectious disease specialist.The patient was discharged home from long term care without further complication.No additional patient consequences have been 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: 9115177
• MDR Text Key: 165023663
• Report Number: 0002242816-2019-00025
• 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: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2018
• 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: 09/10/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0287-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 104