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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE, FIXATION ,BONE   

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES PLATE, FIXATION ,BONE    Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plate/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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. (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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient received debridement and suture under epidural anesthesia and kirschner wire internal fixation surgery for right foot pain and bleeding. On (b)(6) 2020, the patient was discharged without wound secretion and erythema inflammation. The patient came to our hospital for examination on (b)(6) 2020. Three days ago, several old surgical scars and two skin rubbing wounds were found on the right foot. After incision and contusion, the surrounding area was erythema inflammation. A rash was seen with a small amount of purulent fluid wound secretion. The swelling of the back of the foot was obvious, the skin temperature was slightly higher, the movement of the toes was limited, and no obvious abnormality was found in the other limbs. Therefore, removal of kirschner wire was performed for the patient. After surgery, the patient's condition is generally good, the signs are stable, the pain of the affected limb is improved, the incision has been opened, no wound secretion and erythema inflammation. This report is for one (1) unknown plate. This is report 2 of 3 for (b)(4).
 
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Brand NameUNK - PLATES
Type of DevicePLATE, FIXATION ,BONE   
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10587573
MDR Text Key208581626
Report Number8030965-2020-07448
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received09/01/2020
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: 09/25/2020 Patient Sequence Number: 1
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