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: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38
  • 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
 

MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38 Back to Search Results
Catalog Number 04.01.0163
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 09/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on 09 october 2018 lot 172585: (b)(4) items manufactured and released on 12 october 2017.Expiration date: 2022-10-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
While performing the final tightening of the screw, the head of the inner screw broke off.The surgeon was able to recover it.The surgery was completed successfully and without delay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38
Common Device Name
GLENOID POLYAXIAL LOCKING SCREW
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7946595
Report Number3005180920-2018-00783
Device Sequence Number1386762
Product Code PHX
UDI-Device Identifier07630040706506
UDI-Public07630040706506
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K170452
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/08/2022
Device Catalogue Number04.01.0163
Device Lot Number174286
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2018
Initial Report FDA Received Date10/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age68 YR
-
-