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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.244S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Based on the information available, it has been determined that no corrective and 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 history lot manufacturing location: (b)(4).Manufacturing date: 20-oct-2017.Expiration date: 01-oct-2027.Part number: 04.037.244s, 12mm/130 deg ti cann tfna 235mm / right- sterile.Lot number: h478723 (sterile).Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿tfna blade missed the nail¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this 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.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date, the patient underwent the surgery with the fns implants.On an unknown date, the surgeon confirmed that non-union occurred.The patient will undergo the revision surgery to remove the implants.It is non-union because the bone quality was not good, and the blood flow stagnated at the time of injury.The implant was removed successfully on (b)(6) 2020.No further information is available.This complaint involves four (4) devices.This report is for (1) unk - screws: locking.This is report 4 of 4 for (b)(4).
 
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Brand Name
12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10810152
MDR Text Key217442283
Report Number8030965-2020-08777
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819651241
UDI-Public(01)07611819651241
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.037.244S
Device Lot NumberH478723
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/14/2020
Initial Date FDA Received11/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2017
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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