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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION

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SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION Back to Search Results
Catalog Number UNK - CONSTRUCTS: PLATE/SCREWS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). 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. This report is for an unknown screw or plate/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. 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.
 
Event Description
This report is being filed after the review of the following journal article: warnhoff, m. Et al. (2021), double plating - surgical technique and good clinical results in complex and highly unstable proximal humeral fractures, injury, vol. 52, pages 2285-2291 (germany). The aim of this study was to evaluate an operative technique using an angular stable lateral plate supported by a one-third tubular plate positioned anteriorly at the lesser tuberosity for unstable proximal humeral fractures. Patients treated with a double plate osteosynthesis were included between january 2014 and december 2017. Thirty-one patients were treated with open reduction and internal fixation via locked plating (philos ¿proximal humeral plate, depuysynthes, umkirch, germany) and an additional one- third tubular plate (depuysynthes, umkirch, germany) at the lesser tuberosity. There were 19 males and 12 females with a mean age of 54. 7 years ±12. 1 (range, 26 ¿77 years). The mean follow-up was 30. 9 months (range, 12-76 months). The following complications were reported as follows: 2 patients had died of unrelated causes. 11 patients presented clinical signs of subacromial impingement, two of which already underwent implant removal. Both stated that implant removal benefitted them. Overall, 9 patients had their implants removed, 5 in combination with arthroscopic arthrolysis. Six of the 9 patients had a partial stiffness of the shoulder ranging from medium difficulties to se- vere lack of mobility. For 3 patients, the implant-removal was specifically requested by the patient without radiological or clin- ical correlate. All 9 patients stated that implant-removal and arthrolysis benefitted them. 3 patients had fair results (56 - 70 points). 3 patients had poor results (<56). A (b)(6) male patient had implant removal at 6 months post-op. A (b)(6) female patient had reverse arthroplasty because of necrosis of the humeral head at 32 months post-op. A (b)(6) male patient had reverse arthroplasty because of necrosis of the humeral head at 18 months post-op. A (b)(6) female patient had implant removal and arthrolysis at 9 months post-op. A (b)(6) male patient had implant removal and arthrolysis at 9 months post-op. A (b)(6) female patient had implant removal and arthrolysis at 17 months post-op. A (b)(6) male patient had revision surgery due to neurolysis radial nerve at post-op day 1. A (b)(6) male patient had implant removal at 4 months post-op. A (b)(6) male patient had implant removal at 5 months post-op. A (b)(6) male patient had implant removal at 4 months post-op. A (b)(6) male patient had implant removal and arthrolysis at 7 months post-op. A (b)(6) male patient had implant removal and arthrolysis at 4 months post-op a (b)(6) female patient had anatomic arthroplasty because of nonunion at 15 months post-op. This report is for an unknown synthes philos and a 1/3 tubular plate. This report is for an unknown synthes philos plate and screws constructs. This report captures the reported a (b)(6) female patient had anatomic arthroplasty because of nonunion at 15 months post-op. This is report 6 of 15 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14249640
MDR Text Key290369744
Report Number8030965-2022-02801
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/28/2022
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? No
Device Operator
Device Catalogue NumberUNK - CONSTRUCTS: PLATE/SCREWS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

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