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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS SCREW, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); Impaired Healing (2378); Post Operative Wound Infection (2446); Muscle/Tendon Damage (4532)
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). 510k: this report is for an unk - screws: spine/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 product was received; no conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, no further action is required at this time. Complaint information is trended on a regular basis to determine if further investigation is warranted. 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: lv f. , (2021) comparative analysis of the effects of ao miniplate and kirschner wire pinning in the metacarpal fractures, medicine volume 100, pages 1-6 (china). This retrospective study aims to compare and analyze the application effect of ao mini-plate screw and kw fixation in the treatment of metacarpal fracture, which is reported as follows. March 2016 to march 2019, 590 patients with the metacarpal fracture were admitted and recruited in this study including 335 males and 255 females. The mean age of the patients was 28. 45 years (range 18¿45years). Three hundred patients (178 males and 122 females) age 29. 45±2. 51 years treated with ao mini plate and screw fixation were included in the ao group, and 290 patients (157 males and 133 females) age 27. 5±3. 31 years treated with kw fixation were included in the kw group. Patients in both groups were followed up for 3 to 6months after operation. The following complications were reported: 7 wound infection, 7 tendon adhesion, 5 delayed healing, 4 loss of extension compared with contralateral digit, degree (range 1-25), 10 loss of flexion compared with contralateral digit, degree (range 0-70), 20 bad recovery of affected limb joint function 3 months after operation. 6 loose internal fixation. This report is for an unknown synthes ao mini plate and screw. This report is for one (1) unk - constructs: plate/screws. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DeviceSCREW, 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 Key12665817
MDR Text Key277438619
Report Number8030965-2021-08819
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
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
Date Manufacturer Received11/26/2021
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: 10/20/2021 Patient Sequence Number: 1
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