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

MAUDE Adverse Event Report: SYNTHES GMBH LCP DHS-PL 135 2HO L60 STANDBARREL SST PLATE,FIXATION,BONE

  • 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
 

SYNTHES GMBH LCP DHS-PL 135 2HO L60 STANDBARREL SST PLATE,FIXATION,BONE Back to Search Results
Catalog Number 02.224.222S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation could not be completed. No conclusion could be drawn, as no product was received. 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the dhs plate did not get placed on the screw. Due to the standard dhs screw being deformed or bent during the unknown surgery. No patient consequence was reported. This report is for one (1) lcp dhs-pl 135° 2ho l60 stand barrel sst. This is report 1 of 2 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLCP DHS-PL 135 2HO L60 STANDBARREL SST
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12008985
MDR Text Key256503948
Report Number8030965-2021-04975
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.224.222S
Device Lot Number73P8364
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2020
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: 06/16/2021 Patient Sequence Number: 1
Treatment
DHS/DCS-SCR Ø12.5 L105 SST; UNK - SCREWDRIVERS
-
-