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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TOMOFIX OSTEOTOMY PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: TOMOFIX OSTEOTOMY PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - plates: tomofix osteotomy /unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. The 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 Description
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: goshima k. , (2020) factors associated with patient satisfaction after opening-wedge high tibial osteotomy, the orthopedic journal of sports medicine, 8(11),pages 1-10 (japan) syunsuke5552000jp@yahoo. Co. Jp. This retrospective case series aims to evaluate patient subjective satisfaction after owhto and determine the pre- and postoperative factors associated with patient satisfaction after owhto. Between january 2011 and december 2016, 141 consecutive patients (151 knees) (51 males, 100 females) age 64. 3 ¿ 10. 4 (22 to 83 years ) who underwent owhto were enrolled in this study. Some patients were excluded. In total, 123 patients (36 males, 87 females) age 63. 8 ¿ 10. 5 (22 to 83 years ) were included in this study. Fixation was done using a tomofix plate (depuy synthes) was inserted into a subcutaneous tunnel that was formed on the medial side of the tibia and was fixed in place with 8 locking screws. Final cohort were followed up at 54. 6 ¿ 20. 6 (25 to 100) months. The following complications were reported: additional surgery was required for 5 complications, including delayed infection (n
=
3), overcorrection (n
=
1) and late lateral hinge fracture (n
=
1). Wblr significantly changed from20. 7% ¿ 11. 8% (range, _25. 9% to 46. 0%) preoperatively to 66. 9%¿ 10. 2%(range, 33. 1%to 100%) at the final follow-up. Of the 123 patients, 115 underwent hardware removal, and arthroscopic evaluation was performed during plate removal. This report is for an unknown synthes tomofix plate with 8 locking screws. This report is for (1) unk - plates: tomofix osteotomy. This report is 3 of 4 for (b)(4).
 
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Brand NameUNK - PLATES: TOMOFIX OSTEOTOMY
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12543899
MDR Text Key273763325
Report Number8030965-2021-08104
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/28/2021 Patient Sequence Number: 1
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