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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 1H/LT/72MM-SHORT-STER PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 1H/LT/72MM-SHORT-STER PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.117.701S
Device Problem Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation. Part: 04. 117. 701s, lot: 5l45838, manufacturing site: (b)(4), release to warehouse date: 09. Aug. 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.
 
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. 7mm/3. 5mm ti va-lcp ext medl dhp 1h/lt/72mm-short-ster. This is report 5 of 6 for (b)(4).
 
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Brand Name2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 1H/LT/72MM-SHORT-STER
Type of DevicePLATE, FIXATION, BONE
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
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10489191
MDR Text Key205641268
Report Number8030965-2020-06599
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120070
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
Report Date 08/11/2020
1 Device was Involved in the Event
0 Patients were 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 Number04.117.701S
Device Lot Number5L45838
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 Received08/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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