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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - PLATES: TUBULAR PLATE, FIXATION, BONE Back to Search Results
Device Problem Break (1069)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
This report is being filed after the review of the following journal article: davat m. , et al (2021) fracture nonunion of the clavicle after surgical reduction in a (b)(6) girl, the journal of bone and joint surgery volume 11 d number, pages 1-4 ((b)(6)). This study presents a case report of a first situation of a posttraumatic clavicle nonunion after osteosynthesis by plate in a (b)(6) old girl. The had sustained a transverse displaced fracture of the middle third of the right clavicle 3 years earlier. The fracture was initially treated by orif using a synthes one-third 4-hole tubular plate and four 3. 5-mm screws. One and a half year later, the girl complained about increasing pain and described a sensation of movement at the fracture site. An x-ray confirmed implant failure and an atrophic nonunion of the clavicle. Implant was removed and a symptomatic and mobile atrophic nonunion was apparent, and the girl was concerned by the cosmetic appearance of her shoulder. A surgical treatment comprising a pseudarthrosis resection, bone grafting, and intramedullary stabilization was proposed. At the time of the surgery, a freely mobile nonunion was confirmed. Of perioperative bacteriological samples were negative. The atrophic bony ends of nonunion were resected, leading to a significant bone loss. The bone construct was stabilized using a 2. 5-mm esin. Fluoroscopy control confirmed an adequate position of the medial nail end. A sling was used to immobilize the affected limb for 21 days postoperatively. Thereafter, the girl started active mobilization exercises. Four months after the surgery, bone healing was confirmed by radiography. In the meantime, the young patient had recovered a full range of shoulder motion and could return to sportive activities without limitations. The radiograph at 18 months shows nondisplacement of the esin and no complication. Osteosynthesis material removal was proposed 18 months after reconstruction but refused by the patient. This report is for an unknown synthes one-third 4-hole tubular plate and four 3. 5-mm screws. A copy of the literature article is being submitted with this medwatch. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
This report is for an unknown tubular plate/unknown lot. Part and lot number 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. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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.
 
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Brand NameUNK - PLATES: TUBULAR
Type of DevicePLATE, FIXATION, BONE
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 Key14120246
MDR Text Key289356634
Report Number8030965-2022-02470
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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: 04/15/2022 Patient Sequence Number: 1
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