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

MAUDE Adverse Event Report: OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM 2.7MM X 30MM DOUBLE-LEAD LOCKING SCREW, T8

  • 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
 

OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM 2.7MM X 30MM DOUBLE-LEAD LOCKING SCREW, T8 Back to Search Results
Catalog Number 338-2730
Device Problems Break (1069); Human Factors Issue (2948)
Patient Problems No Information (3190); No Code Available (3191); Missing Value Reason (3192)
Event Date 02/22/2018
Event Type  Malfunction  
Event Description

On february 23, 2018 osteomed was notified of an incident with the 2. 7mm x 30 double-lead locking screw, t8. Per the distributor, the surgery center notified him that the physician will be revising the hardware on a patient that currently has an implanted screw that is broken. The patient has had multiple surgeries. During the last surgery on (b)(6) 2018, the physician temporarily removed an implanted 2. 7 sub-condylar plate and added another additive lapidus cage. Then the same sub-condylar plate was implanted back into the patient, along with the 2. 7mm screws previously implanted.

 
Manufacturer Narrative

The root cause for the broken screw could not be determined. The screw was not returned for evaluation. Per the information provided, the surgeon stated "the patient has some comorbidities and lifestyle habits that could make healing a challenge". However, the surgeon declined to answer any additional specific questions regarding the surgery, the health of the patient, or patient conformance to post-surgical instructions claiming hippa concerns. Possible causes for the break include: poor patient health, non-conformance, new trauma, inadequate screw design, non-union of bone, load-sharing, and insufficient bone quality. This screw and the plate in this surgery are intended for temporary fixation only until osteogenesis occurs. Depending on which surgery this screw was implanted during, it broke either 1 month or 5 months after implantation. The lot number was not provided. Therefore, a review of the manufacturing records was not performed. A two-year review of capas, ncrs, and complaints did not identify any similar issues. A review of the fmea shows that risk(s) associated with this failure mode have been assessed. The risk of a loss of fixation requiring revision surgery due to a screw breaking has a severity of 3, which correlates to an injury or impairment requiring professional medical intervention. The probability is ranked as a 1, which correlates to a situation that is unlikely to happen, rare, or remote. Review of the ifu shows that it has multiple warnings and situations that could cause or contribute to implant fracture or failure. It also includes several contraindications regarding certain patient conditions. This issue will be monitored through routine trending.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXTREMILOCK FOOT PLATING SYSTEM
Type of Device2.7MM X 30MM DOUBLE-LEAD LOCKING SCREW, T8
Manufacturer (Section D)
OSTEOMED
3885 arapaho road
addison TX 75001
Manufacturer (Section G)
OSTEOMED
3885 arapaho road
addison TX 75001
Manufacturer Contact
latoia phillips
3885 arapaho road
addison, TX 75001
MDR Report Key7321912
MDR Text Key102112576
Report Number2027754-2018-00007
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131445
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue Number338-2730
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/07/2018 Patient Sequence Number: 1
-
-