MAUDE Adverse Event Report: ORTHO DEVELOPMENT; BONE FIXATION SCREW

Model Number 189-2142

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fracture, Arm (2351)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Product is export only.No 510(k).The device history record was reviewed and showed the device was manufactured according to specification.

Event Description

After initial implantation surgery, the patient fell and reported subsequent pain.An x-ray on (b)(6) 2018 revealed one of the bone screws had backed out.The surgeon plans a revision but it has not yet occurred.

• Type of Device: BONE FIXATION 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: 7511773
• MDR Text Key: 108179138
• Report Number: 1722511-2018-00016
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00822409002832
• UDI-Public: (01)00822409002832(17)220519(10)A178787
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/17/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: 189-2142
• Device Lot Number: A178787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• 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