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 Muscle Spasm(s) (1966); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The event occurred sometime in (b)(6) 2019.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was experiencing sharp pain in his lower back.The pain intensified and the patient was unable to move.The patient was admitted to the hospital for three days.The doctors at the hospital told the patient that it was a severe muscle spasm.The patient was given pain medication.The patient was prescribed medications upon release.The patient has followed up with his general practitioner and states that he is in good health and has not had any problems.No additional patient consequences have been reported.

Manufacturer Narrative

This follow up is being submitted to relay additional information.The device was not returned for evaluation as it is still implanted in the patient.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.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 this report added d4: expiration date 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 4114: device not returned h6: method code updated to 3331: analysis of production records h6: results code updated to 3221: no findings available h6: conclusions code updated to 4315: cause not established h10: additional narratives/data.

Event Description

It was reported that the patient was experiencing sharp pain in his lower back.The pain intensified and the patient was unable to move.The patient was admitted to the hospital for three days.The doctors at the hospital told the patient that it was a severe muscle spasm.The patient was given pain medication.The patient was prescribed medications upon release.The patient has followed up with his general practitioner and states that he is in good health and has not had any problems.It was reported that no further information is available.

• 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: 9289682
• MDR Text Key: 165471076
• Report Number: 0002242816-2019-00037
• 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
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2017
• 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
• Date Manufacturer Received: 03/17/2020
• 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