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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP(TM) DISTAL RADIUS PLATE VOLAR/LEFT-LONG PLATE,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP(TM) DISTAL RADIUS PLATE VOLAR/LEFT-LONG PLATE,FIXATION,BONE Back to Search Results
Model Number 442.492
Device Problem Bent (1059)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Dhr review was completed. Part no. : 442. 492 lot no. : 9123424 manufacturing location: (b)(4). Release to warehouse date: 27. Aug. 2014 no ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product 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.
 
Manufacturer Narrative
Additional device code: hwc. Device is not expected to be returned for manufacturer review/investigation. Patient code (b)(4) used to capture additional medical/surgical intervention required. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review is pending completion. 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
It was reported that a patient was implanted with a synthes titanium (ti) locking compression plate (lcp) distal radius plate volar/left-long, four (4) unknown 2. 4mm ti locking screws, and four (4) unknown 2. 4mm titanium cortex screws to treat an unknown radius fracture on an unknown date in 2017. On an unknown date postoperatively, it was identified that the plate had bent and there was a dorsal displacement of the fracture, identified on preoperative x-rays. On (b)(6) 2017, the patient was returned to the operating room where the implants were removed intact and the patient was revised using a different synthes device. Patient outcome was not reported. Concomitant devices reported: 2. 4mm ti locking screws (part# unknown, lot# unknown, quantity 4), 2. 4mm ti cortex screws (part# unknown, lot# unknown, quantity 4), this report is for one (1) ti lcp(tm) distal radius plate ti lcp(tm) distal radius plate. This is report 1 of 1 for (b)(4).
 
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Brand NameTI LCP(TM) DISTAL RADIUS PLATE VOLAR/LEFT-LONG
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7195998
MDR Text Key113305618
Report Number2939274-2018-50291
Device Sequence Number1
Product Code HRS
UDI-Device Identifier10886982222893
UDI-Public(01)10886982222893(10)9123424
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number442.492
Device Catalogue Number442.492
Device Lot Number9123424
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 Received02/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/27/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/16/2018 Patient Sequence Number: 1
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