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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA LCP VOL-DIST-RADIUSPL2.4 LE SHAFT 5HO HE PLATE, FIXATION, BONE

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SYNTHES ELMIRA LCP VOL-DIST-RADIUSPL2.4 LE SHAFT 5HO HE PLATE, FIXATION, BONE Back to Search Results
Catalog Number 242.468
Device Problem Bent (1059)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
Investigation summary: the complained plate was not returned for evaluation, but the complaint is confirmed as the deformation is visible on the received picture. The manufacturing documents were reviewed and no complaint related issues were found, the plate was manufactured according to the specification. The complaint history was reviewed and there are no other complaints of this nature for the part 242. 468. Without material no definitive root cause can be defined and no further investigation is possible. However, based on the provided information it is likely that a mechanical overload by the mentioned fall did lead to the deformation of the plate. 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. Device 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
Patient information is unknown. Date of event: event date unknown. Additional classification code: hwc. Implanted date: implant date is unknown. Explanted date: explant date is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Concomitant medical product: therapy date of concomitant device is unknown. A device history record review was performed for the subject device lot number 5322933. Manufacturing location:(b)(6). Date of manufacture: 20-sept-2006. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 synthes europe reports an event in (b)(6) as follows: it was reported that a locking compression volar distal radius plate (lcp) has bent when a patient fell over on her out stretched arm. The plate did not fracture but bent and the patient re-fractured the wrist. A revision surgery was performed on (b)(6). 2017. No information available about patient condition and outcome. Concomitant reported parts: 4x unknown screw. This is report 1 of 1 for (b)(4).
 
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Brand NameLCP VOL-DIST-RADIUSPL2.4 LE SHAFT 5HO HE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer (Section G)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7010288
MDR Text Key251566164
Report Number3003506883-2017-10259
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819830189
UDI-Public(01)07611819830189(10)5322933
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number242.468
Device Lot Number5322933
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2006
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: 11/08/2017 Patient Sequence Number: 1
Treatment
4 QTY, UNKNOWN SCREWS.
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