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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/20MM PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/20MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.501.030.01S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Reaction (2414)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative

Patient's birth year reported as (b)(6). Complainant part is not expected to be returned for manufacturer review/investigation. 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 europe reports an event in (b)(6) as follows: it was reported that on on (b)(6) 2020, a patient was treated with a matrixrib plate and screws. Initial procedure was completed successfully. On (b)(6) 2020, the patient returned to the hospital due to fever, pain and redness. The implants need to be removed due to infection. Explantation/part removal will not be performed. No further information provided this report is for one (1) 2. 9mm ti matrixrib lckng screw self-tapping/20mm. This is report 7 of 7 for (b)(4).

 
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Brand Name2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/20MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10344656
MDR Text Key208334349
Report Number8030965-2020-05477
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK161590
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.501.030.01S
Device LOT NumberL363144
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/06/2017
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: 07/30/2020 Patient Sequence Number: 1
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