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

Model Number N/A

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon was operating for revision lumbar pseudoarthrosis to replace hardware and bone grafting, t9 to s1 medtronic hardware and biologics bone grafting, the implantable stimulator did not test positive for implantation and there was not a backup stimulator.Specifically, the test light failed to light up.The stimulator was not used.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.A visual inspection of the returned item was performed.The product was received in a box appearing to be in bad condition.The unit was removed from the tray and has blood on it.After assembling the unit with the tester, the implantable unit was reviewed and it is confirmed the unit works as intended.The tester light turned on, confirming the unit/tester are functional.Unit was tested and the tester light turn on ¿ ¿pass test." output voltage measured 2.80 volts (specification-output voltage from 2.7v ¿ 2.9v) - ¿pass test." output current measured 40.24 ¿a (specification-output current from 38¿a - 42¿a) - ¿pass test." battery of the implant tester was measured and measure 3.26 vdc.Review of the device history records indicates that no abnormal condition was reported.Review of the complaint history determined that no further action is required as no were trends identified.The complaint was not confirmed as the device analysis indicated that the device met specification.A summary of the investigation will be sent to the complainant.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: SPF-XL IIB 2/DW
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 7114318
• MDR Text Key: 95081481
• Report Number: 0002242816-2017-00052
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/15/2018
• Device Model Number: N/A
• Device Catalogue Number: 10-1335W
• Device Lot Number: 224094
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 12/18/2017
• Supplement Dates FDA Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR