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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.433 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

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OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.433 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE Back to Search Results
Catalog Number SD800.433
Device Problem Use of Device Problem (1670)
Patient Problems Skin Erosion (2075); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). This report is for an unknown psi implants: trauma/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthe rep. (b)(4). Without a lot number, the device history records review could not be completed 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that an adverse incident with a psi, lot and reference is unknown. The case number of the psi is: (b)(4). A peek plasty psi with 3 mini plates and 6 screws was implanted (we don't know if the screws are from another commercial house). On (b)(6) 2012 the patient presented a small asymmetry in the plasty psi, as well as in one of the screws of the titanium lower plate that had been released. The same cranioplasty is replaced again, but 4 months later another of the screws is released with the result of another intervention and has an infection altering the bone and osteosynthesis material. On (b)(6) 2012 cranial ct scan is performed again because plasty psi mobility is objective. On (b)(6) 2012 is re-operated by placing the same plasty psi and using a greater number of plates to ensure anchoring. On (b)(6) 2014, a skin lesion occurs due to a continuous rubbing by a screw and is intervened again and with the same plasty psi. The plasty psi does not fit 100% correctly, but they decide not to change it. On (b)(6) 2018 placement of 6 new plates. The patient experience a post-op device malfunction, adverse event, such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing, not well fixation. In addition, the patient require revision surgery, unknown if the device was explanted. Patient consequence were a clinical outcome experienced by the patient (infection, inflammation, infection, pain, and re-interventions, x-rays, additional procedures, prescriptions, otc, revision was required. Concomitant device reported: unknown screws (part #: unknown, lot #: unknown, quantity #: unknown), unknown plates (part #: unknown, lot #: unknown, quantity #: unknown). This complaint involves three (3) device. This report is for one (1) unk - psi implants. This report is 1 of 3 for (b)(4).
 
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Brand NamePSI SD800.433 PEEK IMPLANT
Type of DevicePLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
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
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9507218
MDR Text Key188691853
Report Number8030965-2019-71321
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K053199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSD800.433
Device Lot Number3816404
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/20/2019 Patient Sequence Number: 1
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