MAUDE Adverse Event Report: EBI, LLC. SYSTEM ASSEMBLY- SPINALPAK II; SPINAL STIMULATOR

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ossification (1428); Fatigue (1849); Headache (1880); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Vomiting (2144); Weakness (2145); Depression (2361); Numbness (2415); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

Review of the device history records show that the product was released with no recorded anomaly or deviation.It is reported the stimulator worsened her condition that was caused by the non-zimmer biomet products.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.

Event Description

It is reported through the zimmer biomet (b)(6) that the patient was prescribed the zimmer biomet bone growth stimulator on (b)(6) 2009.It is reported the stimulator worsened her condition that was caused by the non-zimmer biomet products.It is reported the stimulator caused "further uncontrolled bone outgrowth and damage.".

• Brand Name: SYSTEM ASSEMBLY- SPINALPAK II
• Type of Device: SPINAL STIMULATOR
• 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: 6206188
• MDR Text Key: 63319717
• Report Number: 0002242816-2016-00043
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 104600
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2009
• 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): Other; Disability