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 TI MATRIXMANDIBLE SUBCONDYLAR PLATE TRAPEZOIDAL 1.0MM THICK; BONE 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 TI MATRIXMANDIBLE SUBCONDYLAR PLATE TRAPEZOIDAL 1.0MM THICK; BONE PLATE Back to Search Results
Catalog Number 04.503.834
Device Problem Bent (1059)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight not available for reporting.Unknown when device malfunctioned.(b)(4) used to capture additional medical/surgical intervention required.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 europe reports an event in (b)(6) as follows: it was reported patient was implanted with matrixmandible subcondylar plates on both sides of the mandible on (b)(6) 2017.On unknown date it was noted that the plate on the left was broken.Patient was returned to surgery on (b)(6) 2018 where the broken plate was removed.No fragment was left in the patient¿s body.Patient status was reported as fine.Concomitant devices reported: self-tapping non- locking 2 mm screws (part # unknown, lot # unknown, quantity 2), locking self-tapping 2mm screws (part # unknown, lot # unknown, quantity 7), 1.2mm diameter screws with lengths 8mm and 11mm (part # unknown, lot # unknown, quantity 2).During manufacturer¿s preliminary investigation it was identified that customer also returned the bent plate along with the broken plate.This complaint condition of bent plate was re-evaluated and determined to be reportable on march 15, 2018.This report is for one (1) ti matrixmandible subcondylar plate trapezoidal 1.0mm thick.This is report 2 of 2 for complaint (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.Device history records (dhr) review was completed for part# 04.503.834, lot# 7697553.Manufacturing location: (b)(4), manufacturing date: jun 02, 2014.A review of the device history record (dhr) revealed no nonconformance.The dhr shows lot# 7697553 of ti matrixmandible subcondylar plate trapeziodal 1.0mm thick was processed through the normal manufacturing and inspection operations with no nonconformance or rework noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material dhr revealed this lot met all specifications with no nonconformance or rework noted.This complaint is confirmed.The returned plate was received at customer quality (cq) with several post manufacturing bends.An allegation was not reported on the bent plate.Therefore, it is unknown whether the plate was bent preoperatively to fit patient anatomy, bent post operatively while in situ, or whether it was bent intraoperatively during removal.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition.No new malfunctions were identified as a result of the investigation.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant product drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The thickness of the returned plate near bends measured 0.98mm at cq (calipers ca102p) which is within specification of 1.0mm +0.07mm / -0.1mm per drawing.No design issues or manufacturing discrepancies were identified during this investigation.A definitive root cause could not be determined based on the provided information.It is likely that preoperative bending coupled with post-operative forces and possible forces during intraoperative removal contributed to the plate bending.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
Concomitant devices reported: self-tapping non- locking 2 mm screws (part # 02.503.606.05, lot # unknown, quantity 2), locking self-tapping 2mm screws (part # 02.503.406.05, lot # unknown, qunatity 7), 1.2mm diameter screws with lengths 8mm and 11mm (part # unknown, lot # unknown, quantity 2).
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TI MATRIXMANDIBLE SUBCONDYLAR PLATE TRAPEZOIDAL 1.0MM THICK
Type of Device
BONE PLATE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7370429
MDR Text Key103462535
Report Number8030965-2018-52418
Device Sequence Number1
Product Code JEY
UDI-Device Identifier07611819379053
UDI-Public(01)07611819379053(10)7697553
Combination Product (y/n)N
PMA/PMN Number
K091233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.503.834
Device Lot Number7697553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Date Manufacturer Received06/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
-
-