MAUDE Adverse Event Report: EBI, LLC. SPF-PLUS 60/M; STIMULATOR, INVASIVE BONE GROWTH

Model Number N/A

Device Problems Device Damaged by Another Device (2915); Insufficient Information (3190)

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Medical product: zimmer biomet polaris translation std screw implants.Therapy date: (b)(6) 2020.The device 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 was reviewed and no discrepancies related to the reported event 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 3012447612-2020-00485, 3012447612-2020-00486, 3012447612-2020-00487, 3012447612-2020-00488, 3012447612-2020-00489, 3012447612-2020-00490, 3012447612-2020-00491, 3012447612-2020-00492.

Event Description

It was reported that a patient underwent a revision surgery and the original case was an spf and cobalt chrome rod.It was later reported that the polaris translation screws disassembled, which was the reason for the revision surgery.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The device was not returned to (b)(4) for evaluation.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.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.(b)(4) will continue to monitor for trends.

Event Description

It was reported that a patient underwent a revision surgery and the original case was an spf and cobalt chrome rod.It was later reported that the polaris translation screws disassembled, which was the reason for the revision surgery.It was reported that no further information is available.

• Brand Name: SPF-PLUS 60/M
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 10481666
• MDR Text Key: 205272397
• Report Number: 0002242816-2020-00102
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850035
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2024

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: Other
• Device Expiration Date: 03/13/2021
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic