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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH LCP PROXIMAL LATERAL TIBIA PLATE 11 HOLES/260MM-RIGHT; PLATE, FIXATION, BONE
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SYNTHES GMBH LCP PROXIMAL LATERAL TIBIA PLATE 11 HOLES/260MM-RIGHT; PLATE, FIXATION, BONE Back to Search Results
Model Number 222.226
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Codes Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6).Part: 222.226, lot: 9122967, manufacturing site: (b)(4), release to warehouse date: september 02, 2014.A manufacturing record evaluation was performed for the finished article lot and no non-conformances 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.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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, patient underwent a (right) proximal lateral tibial plate revision due to pain and non-union.Proximal screws had backed out.Patient was revised with a variable angle (va) proximal lateral tibial plate and a medial plate.Patient was originally treated on (b)(6) 2021, for a proximal tibial fracture.This report is for a locking compression plate (lcp) proximal lateral tibia plate.This is report 1 of 7 for (b)(4).
 
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Brand Name
LCP PROXIMAL LATERAL TIBIA PLATE 11 HOLES/260MM-RIGHT
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key12561940
Report Number8030965-2021-08227
Device Sequence Number19185949
Product Code HRS
UDI-Device Identifier10886982156631
UDI-Public(01)10886982156631
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K052390
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number222.226
Device Catalogue Number222.226
Device Lot Number9122967
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/01/2021
Supplement Date Received by Manufacturer10/01/2021
Initial Report FDA Received Date10/01/2021
Supplement Report FDA Received Date10/01/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
LOCKSCR Ø5 SELF-TAP L34 SST.; LOCKSCR Ø5 SELF-TAP L55 SST.; LOCKSCR Ø5 SELF-TAP L65 SST.; LOCKSCR Ø5 SELF-TAP L65 SST.; LOCKSCR Ø5 SELF-TAP L80 SST.; UNK - SCREWS: TRAUMA.; LOCKSCR Ø5 SELF-TAP L34 SST; LOCKSCR Ø5 SELF-TAP L55 SST; LOCKSCR Ø5 SELF-TAP L65 SST; LOCKSCR Ø5 SELF-TAP L65 SST; LOCKSCR Ø5 SELF-TAP L80 SST; UNK - SCREWS: TRAUMA
Outcome Attributed to Adverse Event Required Intervention;
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