MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA; PEDICLE SCREW

Model Number 752-7550-01A

Device Problem Use of Device Problem (1670)

Patient Problems Death (1802); Pain (1994)

Event Date 03/01/2018

Event Type  Death  

Event 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 2 of 2.

• Brand Name: PAGODA
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 7892017
• MDR Text Key: 120820352
• Report Number: 1722511-2018-00033
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00822409022564
• UDI-Public: (01)00822409022564(17)221115(10)A185028
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2022
• Device Model Number: 752-7550-01A
• Device Lot Number: A185028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR