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: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
  • 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
 

OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE Back to Search Results
Catalog Number 02.124.417S
Device Problem Break (1069)
Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Additional pro-codes: hwc, hrs.Exp.Date unknown.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 a broken va distal femur plate, revised to lcp condylar plate.Patient needed the plate revised, pt has bilateral hip and knee replacements as well as periprosthetic fractures above both knees, patient is walking, (b)(4).Device property of hospital, device in possession of sterile services.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D6: date of implantation is an unknown date in (b)(6) 2019.H3, h4, h6: part: 02.124.417s; lot: l326443; manufacturing site: mezzovico; release to warehouse date: march 15, 2017; expiry date: march 01, 2027.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: returned items have been received not in original packaging.Information etched match to complaint system and device history record (dhr).The returned plate is broken post production at level of the holes va-2.No evidence of visual nonconformance manufacturing related.Document/specification review: the returned item has been manufactured and then released in february 2017.The involved lot l326443 has been manufactured starting from the forging blank (material: stainless steel 1.4441 as per requirements).No nonconformances or document change have been identified which may be related to the complaint condition.Dimensional inspection: the returned part was reinspected for all the features relevant to the complaint condition.The measurable features (thickness, width and holes features) have been found conforming to manufacturing specifications.Summary: as per selected investigation flow, the investigations performed didn¿t identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
It was further reported that the revision procedure occurred on (b)(6) 2019.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Updated : it was further reported that the plate broke at the second shaft hole, the fracture was not healed, delayed union 5 months post op.The revision was done with locking compression distal femur plate (lcp df) and screws augmented with traumacem.Fracture site also grafted with mtf bone chips.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER
Type of Device
IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8839607
MDR Text Key152603437
Report Number8030965-2019-66643
Device Sequence Number1
Product Code JDP
UDI-Device Identifier07611819455955
UDI-Public(01)07611819455955
Combination Product (y/n)N
PMA/PMN Number
K110354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02.124.417S
Device Lot NumberL326443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Date Manufacturer Received09/25/2019
Patient Sequence Number1
Treatment
LOCKSCR Ø3.5 SELF-TAP L85 SST
Patient Outcome(s) Required Intervention;
Patient Age84 YR
-
-