MAUDE Adverse Event Report: ALPHATEC SPINE INC TITANIUM HEXALOBE SET SCREW, 8.5 MM (TI-6AI-4V ELI); PEDICLE SCREW SPINAL DEVICE

Model Number	22085
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is not possible at this time.The explanted zodiac set screws have not been returned nor have the identifying lot number(s) been provided.The user facility has not released the explanted devices.Upon the receipt of additional information or the product in question, a follow-up report will be submitted.
Event or Problem Description
Revision surgery was conducted on (b)(6) 2016 on a (b)(6) year old female patient.The zodiac set screws located on both sides of the iliac were found to have backed out of position.The zodiac spinal fixation was originally implanted on (b)(6) 2015 from the t10 thru pelvis.

• Brand Name: TITANIUM HEXALOBE SET SCREW, 8.5 MM (TI-6AI-4V ELI)
• Common Device Name: PEDICLE SCREW SPINAL DEVICE
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5663158
• Report Number: 2027467-2016-00029
• Device Sequence Number: 260919
• Product Code: MNI
• UDI-Device Identifier: 00844856043695
• UDI-Public: 00844856043695
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K081158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2016

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?: Yes
• Operator of Device: Physician
• Device Model Number: 22085
• Device Catalogue Number: 22085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2016
• Initial Report FDA Received Date: 05/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 54 YR