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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Pain (1994); Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Event Date 11/26/2014
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plates: locking: calcaneal plate/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. 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.
Event Description
This report is being filed after the review of the following journal article: xu y. , et al (2014) chinese efficacy of hperbaric oxygen therapy combined with locking plate for intra-articular calcaneal fractures, journal of clinical rehabilitative tissue engineering research, volume 18(48), pages 7816¿7821 (china). This study aims to evaluate the effect of the hyperbaric oxygen adjuvant therapy in preventing incisional complications after calcaneal fracture fixation; and (2) evaluate the impacts of the hyperbaric oxygen adjuvant therapy on post-fixation pain, function recovery, and living quality of patients who had calcaneal intra-articular dislocated fractures. From january 2010 to september 2012,a total of 80 patients with calcaneal intra-articular dislocated fractures who underwent the extensile lateral approach for reduction and internal fixation were included in the study. The patients were randomized into two groups, receiving hyperbaric oxygen therapy (hbot group) or hyperbaric air treatment (control group). Each group contained 40 patients. 73 patients were included in the final result analysis. Hbot group contained 37 patients (26 males, 11 females) aged (45. 19-10. 2) years while the control group contained 36 patients (27 males, 9 females) aged (42. 46 -11. 22) years. The calcaneal locking plates used were purchased from shandong weiga orthopedic materials co. , ltd. , suzhou xinrong bo'erte medical device co. , ltd. , changzhou kanghui medical device co. , ltd. , or ao company, and were made of titanium. Patients were followed up after 2 years. The following complications were reported as follows: hbot group: one patient developed superficial infection, which was cured by oral antibiotics and wound dressing change, 1 superficial disruption of wound, 1 incisional infection, incision breaking 1(3), incisional subcutaneous hematoma 1(3) and patients developed posttraumatic subtalar arthritis at 2 years follow-up. Control group: the soft tissue in feet were swollen and darkened , and the swelling had persisted; in some of these patients there was skin darkening. Necrosis , and splitting of the skin at the incisional edge of the calcaneal bone, swelling and pain and other discomforts in the feet and pain during walking, 3 patients developed post-fixation aureus infection; after treatments including anti-infection treatment and repeated debridement and dressing changes, the wounds had healed, 3 patients developed incisional edge necrosis, 1 case of incisional edge necrosis , the skin flap necrosis area was large , and plate was exposed; after the removal of the plate , the skin graft was freed to cover teh wound, superficial disruption of wound, incision breaking 1(2), incisional subcutaneous hematoma 2(5), superficial infection 2(5), deep infection 1(2), one patient in the in the control group (with a sanders type of iv) felt obvious pain in the ankle during follow 2 years after the fixation, which is aggravated during walking. Imaging examinations showed an increase in density of the subtalar joint and narrowing of the joint space , which were diagnosed as traumatic arthritis of the subtalar joint, and fusion of subtalar joint was performed and patients developed posttraumatic subtalar arthritis at 2 years follow-up. This report is for an unknown synthes ao calcaneal locking plates.
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
MDR Report Key11868820
MDR Text Key266018417
Report Number8030965-2021-04158
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,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2021
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 Received04/26/2021
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: 05/23/2021 Patient Sequence Number: 1