MAUDE Adverse Event Report: EBI, LLC. SOLITAIRE-C SPACER SYSTEM; SOLI-C 3.5X14MM SCREW

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/12/2013

Event Type  Injury  

Manufacturer Narrative

The returned soli-c screw was found with only slight surface abrasion along the threading.There is no indication that the event was caused by the design or manufacturing of the device.All proper material certs are attached with the manufacturing records and no deviations are noted.The probable underlying root cause for the reported incident is metal allergy as described by the patient.The ifu includes under contraindications, "metal sensitivity/allergies to the implant materials.".

Event Description

It was reported, patient failed to inform dr.That she had a titanium allergy.Subsequently, patient suffered an adverse reaction and needed a revision surgery to remove the implant and replace it with an allograft product.Patient outcome: no further adverse effect reported.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same event (also see 0002242816-2014-00005 & 00006).

• Brand Name: SOLITAIRE-C SPACER SYSTEM
• Type of Device: SOLI-C 3.5X14MM SCREW
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: david talish ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 3582662
• MDR Text Key: 11616431
• Report Number: 0002242816-2014-00006
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• 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: 14-531714
• Device Lot Number: PV44C
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention