MAUDE Adverse Event Report: OSTEOMED 2.0MM X 8MM FULLY THREADED SCREW, ANGLED LOCKING; HAND PLATING SYSTEM

Catalog Number	330-2008
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(4) 2018, osteomed was notified of an adverse event related to a patient.Per the information received, the patient received implants on (b)(6) 2017.The implants were removed on (b)(6) 2018.No additional information was received.
Additional Manufacturer Narrative
The devices were not returned.Therefore, an evaluation could not be performed.The lot number was unknown.Therefore, a review of the specific dhrs for the devices associated with this complaint could not be performed.A two-year review of complaints was performed.The review shows that the this is the only complaint received within the last 2 years for all the devices referenced except p/n 330-2014 and p/n 331-2012.Both of these devices had one additional complaint for a broken screw head.But neither of the complaints resulted in an adverse event.For each system that these implants are part of, there is a documented risk document that addresses multiple situations that could cause/contribute to implant failure.However, without the details of why the devices were explanted, we are unable to confirm that the failure modes have been assessed.Each system also has an ifu that addresses multiple warnings, contraindications, and situations that could cause/contribute to implant failure.Without the details of why the devices were explanted, we are unable to confirm that the osteomed labeling addresses issue experienced.Therefore, a full investigation could not be completed.Should osteomed receive additional information to conduct a full investigation, an amendment to this report will be added.
Event or Problem Description
Osteomed was notified of an incident related to a patient.Per the information received, the patient received implants on 08/31/2017.The listing of implants were provided.The implants were removed on 02/09/2018.No additional information was received.Following a search to determine if the incident had been previously reported, it was determined that prior notification was not in our system.Therefore, a complaint for each part number referenced has been initiated to document this incident as an adverse event.

• Brand Name: 2.0MM X 8MM FULLY THREADED SCREW, ANGLED LOCKING
• Common Device Name: HAND PLATING SYSTEM
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 7823991
• Report Number: 2027754-2018-00029
• Device Sequence Number: 16478153
• Product Code: HWC
• UDI-Device Identifier: 00845694023528
• UDI-Public: 00845694023528
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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 Catalogue Number: 330-2008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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: Required Intervention
• Patient Age: 54 YR