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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/LT/88MM-MED-STER PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/LT/88MM-MED-STER PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.117.104S
Device Problem Material Twisted/Bent (2981)
Patient Problems Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation. Part: 04. 117. 104s, lot: 5l23854, manufacturing site: (b)(4), release to warehouse date: 11. Jul. 2019, expiry date: 01. Jul. 2029. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. Product was not returned. 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. (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 an unknown date in (b)(6) 2019 the patient underwent surgery for a distal humeral fracture using the 2. 7mm/3. 5mm variable angle lcp elbow system. It was not reported how the surgery was completed. On (b)(6) 2020, the removal surgery was performed. During the removal surgery, screw heads of the three (3) locking screws (lateral plate: 2 and medial plate: 1) stripped. The surgeon used an extraction instrument by removing the screw head and tried to remove the three locking screws after cutting the bone around the screws with a hollow reamer. As the screw head of one (1) locking screw implanted at a medial plate was stuck in the extraction instrument, the surgeon removed this locking screw while using the hollow reamer together. The other two (2) locking screws implanted at a lateral plate were also removed by using only the extraction instrument. All the locking screws were successfully removed. There were no broken parts left in the patient¿s body however, the bone defects occurred on the bone surface. There was a 120-minute surgical delay. This report is for one (1) 2. 7/3. 5 ti va-lcp postlat dhp- lat supt 4h/lt/88mm-med-ster. This is report 4 of 6 for (b)(4).
 
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Brand Name2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/LT/88MM-MED-STER
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10489150
MDR Text Key205652388
Report Number8030965-2020-06598
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.117.104S
Device Lot Number5L23854
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 Received10/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2019
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: 09/03/2020 Patient Sequence Number: 1
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