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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L95 TAN ROD,FIXATION,INTRAMEDULLARY

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OBERDORF : SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L95 TAN ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.034S
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient gender and weight not available for reporting. Date of implant is not known complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. (b)(4). 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 that the patient underwent hardware removal on (b)(6) 2018 due to prominence of the implanted proximal femoral nail anti rotation (pfna) blade. The blade was removed, but pfna nail and distal locking screw were left in the patient. It is unknown if there was a surgical delay or what the patient outcome was. It is not known where or when the pfna construct was implanted. Concomitant devices reported: pfna nail (part number unknown, lot number unknown, quantity 1), distal locking screw (part number unknown, lot number unknown, quantity 1). This report is for one (1) pfna blade. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA BLADE PERF L95 TAN
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf PA 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7838337
MDR Text Key118939933
Report Number2939274-2018-53568
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.034S
Device Lot NumberL560129
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 Received10/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2017
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: 08/31/2018 Patient Sequence Number: 1
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