MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA; PEDICLE SCREW

Model Number 752-6545-11A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

No revision surgery was performed so the device was not returned for evaluation.A supplemental report is not anticipated unless additional relevant information is received.Should the product or additional relevant information become available, an evaluation will be conducted and a supplemental report filed with the results.

Event Description

During a clinical visit 8 months post surgery, the surgeon noted that two screws had broken on both sides of s1.No revision was performed.

• 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: 6980607
• MDR Text Key: 91103296
• Report Number: 1722511-2017-00005
• Device Sequence Number: 1
• Product Code: NKB
• 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: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 752-6545-11A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR