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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM TI MATRIXRIB STRAIGHT PL 30 HOLES/300MM LENGTH; PLATE, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM TI MATRIXRIB STRAIGHT PL 30 HOLES/300MM LENGTH; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.501.097
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Erosion (2075); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Date of implant reported as (b)(6) 2017, exact date not known.Date of explant reported as (b)(6) 2018, exact date not known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes affiliate.Patient code (b)(4)-no code available used to capture required intervention when plate was exposed through the skin.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Patient underwent a chestwall reconstruction surgery in (b)(6) 2017.On unknown date in (b)(6) 2017 and (b)(6) 2018, two (2) of the three (3) plates inserted eroded through the patient's skin.A portion of the plates had to be removed.Surgeon stated that patient's skin was very thin and was likely malnourished due to cancer.Patient also had previous radiotherapy done approximately 8-10 years ago.This report addresses the removal surgery in (b)(6) 2018.The removal surgery in (b)(6) 2017 is addressed in (b)(4).This report is for one (1) 1.5mm matrixrib straight plate this is report 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.Udi: this information is available.Product was not returned and no lot number was provided.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.Complaint is confirmed as the erosion through patient's skin is visible on the received pictures.The risk assessment for matrixrib addresses the hazard ¿implant palpable¿ resulting in soft tissue damage ¿ major.The dcrm document adequately addresses the complaint condition.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.
 
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.H11: b1, b5, h1: the initial complaint was reviewed and found not reportable.This complaint has been verified to be a duplicate of pc-000170133.Therefore, this complaint will be voided.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
The initial complaint was reviewed and found not reportable.This complaint has been verified to be a duplicate of pc-000170133.Therefore, this complaint will be voided.
 
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Brand Name
1.5MM TI MATRIXRIB STRAIGHT PL 30 HOLES/300MM LENGTH
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7493002
MDR Text Key107561736
Report Number8030965-2018-53602
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K161590
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 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number04.501.097
Was Device Available for Evaluation? No
Date Manufacturer Received07/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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