Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 2.0X6MM, UPPERFACE, (5/PACKAGE); IMPLANT
  • 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
 

STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 2.0X6MM, UPPERFACE, (5/PACKAGE); IMPLANT Back to Search Results
Model Number 50-20906
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problems Erythema (1840); Foreign Body Reaction (1868); Fluid Discharge (2686)
Event Date 07/03/2020
Event Type  Injury  
Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device evaluated by manufacturer? discarded at facility.
 
Event Description
The patient had a mandibular fracture, and two plates and their associated bone screws were used during the procedure.Post-operatively the patient presented repeated submental redness and exudation, and showed no significant improvement after 1 month of treatment with anti-inflammatory medications and local dressing changes.As a result, the patient had the plates and screws explanted.There is no indication that the implants did not act as intended.
 
Manufacturer Narrative
The devices were not returned for investigation nor any documents (e.G.Lab results for the alleged titanium) were received for investigation that could confirm the reported event.Upon review of the reported devices, it should be noted that the implants are from different modules and are not intended to be used in combination with each other.In a follow-up, it was mentioned that the alleged titanium rejection appeared after a month post-operatively.Patient received anti-inflammatory treatment.The location of the observed redness and discharge was at the surgical site.Samples from the reported discharge from the surgical site was not taken for laboratory analysis.Further, allergy tests to determine if patient is suffering from titanium rejection were not conducted.However, surgeon stated that the event is a non-infectious inflammation and is negative for bacterial culture.Implants were removed on (b)(6) 2020, as no improvement was seen with regards to patient¿s condition.After implant removal, patient¿s mouth is healed.This event was presented to stryker¿s medical expert.He stated that ¿based on the report of symptoms, this does not appear to be a hypersensitivity reaction to the titanium, rather it appears to be an infection.¿ in sum, the reported event could not be confirmed, nor a root cause could be established as the received information from the customer is insufficient.Based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.
 
Event Description
The patient had a mandibular fracture, and two plates and their associated bone screws were used during the procedure.Post-operatively the patient presented repeated submental redness and exudation, and showed no significant improvement after 1 month of treatment with anti-inflammatory medications and local dressing changes.As a result, the patient had the plates and screws explanted.There is no indication that the implants did not act as intended.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 2.0X6MM, UPPERFACE, (5/PACKAGE)
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM  D-79111
MDR Report Key10896786
MDR Text Key218167212
Report Number0008010177-2020-00060
Device Sequence Number1
Product Code JEY
UDI-Device Identifier34546540602993
UDI-Public34546540602993
Combination Product (y/n)N
PMA/PMN Number
K022185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number50-20906
Device Catalogue Number50-20906
Device Lot Number1000387138
Was Device Available for Evaluation? No
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-