MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA; PEDICLE SCREW

Model Number	752-7545-11A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Death (1802); Pain (1994); Patient Problem/Medical Problem (2688)
Date of Event	03/01/2018
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2018, a revision surgery was performed to extend existing l4-l5 pedicle screw fixation to l3-s1.The surgery also involved vertebroplasty of l5 together with l5-s1 tlif using another manufacturer's cage.During surgery, the patient's blood pressure began to drop and the patient expired.The report indicated the patient's left iliac artery was most likely perforated when pushing the rod onto the screw.The surgeon stated this incident was due to a technical error and not the pedicle screw.Two pedicle screws were in use but it is unknown which screw was involved so two identical medwatch reports are being filed, one for each part number.This is report 1 of 2.
Additional Manufacturer Narrative
This follow up report #1 corrects 2 errors in the initial report.Manufacture date corrected from 30-nov-2017 in the initial report to 18-sep-2017 in this follow up.(b)(4).

• Brand Name: PAGODA
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 7891960
• Report Number: 1722511-2018-00032
• Device Sequence Number: 2726222
• Product Code: NKB
• UDI-Device Identifier: 00822409022519
• UDI-Public: (01)00822409022519(17)220810(10)A180776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: 752-7545-11A
• Device Lot Number: A180776
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: Death
• Patient Age: 75 YR