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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 6.0MM TI HARD ROD 75MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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OBERDORF : SYNTHES PRODUKTIONS GMBH 6.0MM TI HARD ROD 75MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 498.103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

Patient gender and weight not available for reporting. Date reaction began is not known. Additional product codes: mni, mnh, kwp, kwq. Device was not explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Facility address not available for reporting. Device is not distributed in the united states, but is similar to device marketed in the usa. 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

It was reported patient was implanted with a 6. 0mm titanium hard rod, a titanium universal spine system (uss) low profile fracture clamp, and a 6. 2mm titanium schanz screw with dual core on (b)(6) 2016 for a column fracture at t12. On unknown date patient presented with a skin reaction comparable with an allergy. Reaction was treated for almost a year with antihistamines but proved difficult to control. A biopsy was performed on unknown date, results are not known. Patient currently maintains slight skin lesions on the thighs and legs. This report is for one (1) 6. 0mm titanium hard rod. This is report 3 of 3 for (b)(4).

 
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Brand Name6.0MM TI HARD ROD 75MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf PA 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7814806
MDR Text Key241263967
Report Number2939274-2018-53474
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeCI
PMA/PMN NumberK090605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number498.103
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 Received09/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/24/2018 Patient Sequence Number: 1
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