MAUDE Adverse Event Report: ALPHATEC SPINE INC TI 8.5 MM POLYAXIAL SCREW ASSY, 45 MM (TI-6AI-4V ELI); PEDICLE SCREW SPINAL FIXATION

Model Number	62085-45
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	08/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The second polyaxial screw reported is of the same product part number but contains a separate manufacturing lot number ; a 692540 manufactured 6/1/2015.An evaluation is not possible at this time.The user facility has not returned the proximal sections of the explanted polyaxial screws to the international distributor.A review of the device history records revealed no manufacturing, processing or design related irregularities.The records indicate the implants were properly manufactured and released in accordance with design specifications.Upon the receipt of additional information and/or the implants in question, a follow up report will be submitted.
Event or Problem Description
Post op x-rays taken (b)(6) 2016 revealed two (2) polyaxial screws located at l5 had fractured and broke.Revision surgery was conducted (b)(6) 2016 to remove and replace the zodiac construct.The proximal sections of both screws were removed without issue, while the distal threaded portions remain entrapped within the right & left side of the patients l5.The zodiac degenerative spinal fixation system was originally implanted on (b)(6) 2015 from the l3 to l5.

• Brand Name: TI 8.5 MM POLYAXIAL SCREW ASSY, 45 MM (TI-6AI-4V ELI)
• Common Device Name: PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5998069
• Report Number: 2027467-2016-00076
• Device Sequence Number: 348045
• Product Code: KWP
• UDI-Device Identifier: 00844856003248
• UDI-Public: 00844856003248
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2016

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?: No
• Operator of Device: Physician
• Device Model Number: 62085-45
• Device Catalogue Number: 62085-45
• Device Lot Number: 683893
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Initial Report FDA Received Date: 10/04/2016
• 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: 65 YR