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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Bone Fracture(s) (1870); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Discomfort (2330); Hypoesthesia (2352); Reaction (2414); Foreign Body In Patient (2687); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown synthes plate/screws construct/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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. (b)(4).
Event Description
This report is being filed after the review of the following journal article: hou, y. F. Et al (2015), possible predictors for difficult removal of locking plates: a case-control study, injury, vol. 46 (issue 6), pages 1161-1166 (china). The aim of this study is to investigate possible factors related to the difficult removal of lcps/lisss and to provide information and suggestions for orthopaedic surgeons with respect to decision making regarding the removal of locking plates and the prevention of complicated removal. Between september 2004 to november 2013, a total of 308 patients (190 male and 118 female) with a median age of 34 years (inter-quartile range, 25-48) underwent lcp/liss (depuy synthes, paoli, pa, usa) removal. The following complications were reported as follows: 6 out of 15 patients with peri-elbow fractures and five out of 17 patients with femur fractures suffered difficult removal, while 4 out of one hundred patients with malleolar fractures had intra-operative difficulties. Incidences of difficult removal in upper extremities is 41. 7 percent in distal humerus, 33. 3 percent in proximal forearm, 20. 8 percent in proximal humerus, 20 percent in both forearm diaphysis and humerus diaphysis. Incidences of difficult removal in lower extremities is 33. 3 percent in both proximal femur and femur diaphysis, 20 percent in distal femur, 18. 5 percent in distal tibia, 14. 3 percent in tibia diaphysis, 9. 8 percent in proximal tibia and 4 percent in malleolus. 231 patients underwent removal without any complaints. 18 patients underwent removal due to mobility impairment. 16 patients underwent removal due to pain. 10 patients underwent removal due to discomfort. 7 patients underwent removal due to soft tissue irritation. 5 patients underwent removal due to subcutaneous infection. 1 patient underwent removal due to articular adhesions. 1 patient underwent removal due to parasthesia. 2 patients experienced refracture. In one patient with a distal humerus fracture, the surgeon found a bone split and used cast fixation after removal. The other patient, who had a forearm diaphysis fracture, suffered a radius refracture in a fall one month after removal and underwent open reduction and lcp fixation. 2 patients suffered radial nerve palsy and recovered after the administration of cortisone, mannitol and nutritional nerve drugs. 5 lhss and 1 reconstruction lcp were difficult to expose for fear of radial nerve injury. 3 patients retained their implants: 1 in a distal humerus fracture who suffered a severe subcutaneous infection and did not recover until receiving a skin flap transfer operation for wound coverage. The other 2 in distal tibia fractures. 1 lcp reconstruction plate 3. 5, 1 lcp distal tibia plate 2. 7/3. 5, 1 lcp t distal radius plate 2. 4, 16 3. 5-mm lhss and 1 2. 4-mm lhss were retained. 37 patients experienced intraoperative difficulties with 30 of 338 lcps, 7 of 32 lisss, 67 of 1533 small-diameter (
3. 5-mm) lhss, and 12 of 442 large-diameter (
4. 5-mm) lhss. There were many types of intraoperative difficulties such as lhs slipping, lhs jamming, lhs hard for exposure, lhs broke when using conical extraction screw, lhs broke when levering the plate and bone ingrowth, and the surgeon rectified most of them. 1 male patient experienced iodine contact dermatitis and subcutaneous effusion. He was treated successfully with oral antibiotics and syringe aspiration of the effusion. 5 patients underwent removal due to plate displacement. 13 patients underwent removal due to a broken plate, in which 7 of these patients had a healed fracture while 6 patients underwent revision surgery. 4 lhss broke when the surgeons used a conical extraction screw (ces). 1 lhs broke when levering the plate. This report is for an unknown synthes plate/screws construct. This is report 1 of 7 for complaint (b)(4). It captures the adverse events of medical device removal, mobility impairment, pain, discomfort, soft tissue irritation, subcutaneous infection, adhesions, parasthesia, refracture, radial nerve palsy, bone in growth, fracture and surgical intervention.
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key9146298
MDR Text Key167335512
Report Number8030965-2019-68925
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
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 Received09/06/2019
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: 10/02/2019 Patient Sequence Number: 1