• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONUMENT SYNTHES USA LLC UNK - RODS ROD, FIXATION, INTRAMEDULLARY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MONUMENT SYNTHES USA LLC UNK - RODS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown rod/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that in (b)(6) of 2014 that the patient was implanted with metal rods to stabilize the patient's spine. It was reported that following the surgery, the patient developed severe and prolonged back pain. It was reported that in (b)(6) of 2016, the patient had imaging performed in relation to the patient's back pain. It was reported that the imaging determined that the rods in the patient's spine had broken. It was reported that in (b)(6) of 2017, the patient underwent a second surgery to repair the broken rods. It was reported that the patient sustained injuries including severe pain, chronic pain, unnecessary surgery, prolonged hospital admissions, and such and other injuries. It was reported that as a result of the injuries, the patient experienced and continues to experience pain, disability, inconvenience and a loss of enjoyment of life; experiences interference with normal, everyday activities as well as secondary complications. This report is for one (1) unknown rod. This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - RODS
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
MONUMENT SYNTHES USA LLC
1200 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11349049
MDR Text Key232573770
Report Number1719045-2021-00001
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/19/2021 Patient Sequence Number: 1
-
-