MAUDE Adverse Event Report: EBI, LLC. POLARIS SPINAL SYSTEM; BONE SCREW

Model Number N/A

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Event Description

It is reported the original surgery was performed (b)(6) 2010.On an unknown date, the patient reported walking in the mall and felt a pop and pain.Patient reports proceeding to the emergency room where a fractured screw was identified.Subsequently, a revision surgery was performed on (b)(6) 2015 and the implants were removed; with the exception of a portion of the screw which could not be removed from the patient's fifth lumbar vertebra (l5).The patient's current physician allegedly indicates "the main factor was the non-union, but does not have a specific cause.".

Manufacturer Narrative

It is reported the patient requested the explanted devices, therefore no product will be returned to the manufacturer for evaluation.The warnings in the package insert state possible adverse effects include, but are not limited to: bending, loosening or fracture of the implants or instruments.The user facility is foreign; therefore, a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.File one of five for the same event, see also 2242816-2015-00066, 2242816-2015-00067, 2242816-2015-00068 and 2242816-2015-00069.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.(b)(4).Supplemental report one of five for the same event, reference 2242816-2015-00066-1, 2242816-2015-00067-1, 2242816-2015-00068-1 and 2242816-2015-00069-1.An additional lot number for part number 6451 was received that was not initially reported, reference 2242816-2015-00089.

Manufacturer Narrative

The returned explanted devices were visually evaluated, no issues were identified.Based on the information provided there were no reported issues with the hardware that was removed with the exception of one broken screw (p/n 50-6109mp lot 87472).The root cause cannot be fully determined.However, it is likely that the screw fractured due to loading on the device over the course of the 4+ years it was implanted without fusion.As discussed in the labeling, the screws are not designed nor labeled for being the sole means of spinal support and will eventually break or fracture if solid fusion is not present.Per the reporter and the treating physician, the nonunion contributed to the screw fracturing.There were no manufacturing issues detected that would have contributed to this event.Supplemental report one of six for the same event, reference 2242816-2015-00066-2, 2242816-2015-00067-2, 2242816-2015-00068-2, 2242816-2015-00069-2 and 2242816-2015-00089-1.

• Brand Name: POLARIS SPINAL SYSTEM
• Type of Device: BONE SCREW
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 4881680
• MDR Text Key: 6043764
• Report Number: 0002242816-2015-00065
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PK141804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 50-6106MP
• Device Lot Number: 01349
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 78