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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH LCP 2.7 STRAIGHT 5HO L49 TI ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE

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SYNTHES GMBH LCP 2.7 STRAIGHT 5HO L49 TI ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE Back to Search Results
Catalog Number 449.681S
Device Problem Device-Device Incompatibility (2919)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/25/2022
Event Type  Injury  
Manufacturer Narrative
Additional narrative: 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. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. (b)(4). Investigation summary: 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. A manufacturing record evaluation was performed for product code: 449. 681 with lot number: 72p2459; and no non-conformances were identified.
 
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent an unknown surgery with the lcp plate and the four cortex screws for the pediatric forearm fracture. According to the report, the removal surgery was performed on (b)(6) 2022 of the four cortex screws successfully. However, it was reported that the surgeon had difficulty removing the lcp plate device. It was reported that the surgeon decided not to remove the plate forcefully. The surgery was completed successfully with the plate remaining in the patient¿s body. The status of the patient post-removal was reported to be stable. No additional information was provided. This report is for one (1) lcp 2. 7 straight 5ho l49 ti device. This complaint involves one (1) device.
 
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Brand NameLCP 2.7 STRAIGHT 5HO L49 TI
Type of DeviceORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BALSTHAL (CH)
dornacherstrasse 20
balsthal 4710
SZ 4710
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14253946
MDR Text Key290447034
Report Number8030965-2022-02840
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K063049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number449.681S
Device Lot Number7L42915
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
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