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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pocket Erosion (2013); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Multiple patient involved. Implantation date unknown. 510k: this report is for an unk - plates: cmf/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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. (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. (b)(4).
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: rendenbach c et al. , (2019) complication rates and clinical outcomes of osseous free flaps: a retrospective comparison of cad/cam versus conventional fixation in 128 patients, international journal of oral maxillofacial surgery volume 48 (9), pages 1156¿1162 (germany) https://doi. Org/10. 1016/j. Ijom. 2019. 01. 029. This retrospective single-center cohort study aims to compare the clinical outcomes and complication rates of mandible reconstruction with conventional and patient-specific cad/cam reconstruction plates, with special attention to dental rehabilitation and independent risk factors. Between january 2011 and december 2015,a total of 128 patients (82 males and 46 females) with an average age of 59. 2 - 12. 4 years met the inclusion criteria of initial flap survival. The study population was divided into two groups in order to compare reconstruction characteristics and complication rates between patients with conventional (n
91) and patient-specific cad/cam (n
37) plates. Flap fixation was performed with intraoperatively bent conventional reconstruction plates (bars) of 2. 0¿2. 5 mm thickness or patient-specific laser-melted plates derived from cad/cam planning procedures of different manufacturers (depuy synthes, umkirch, germany; kls martin group, tuttlingen, germany). The average follow- up was 15. 5 months. The following complications were reported as follows: the most common complication was subtotal osseous union, which occurred in 47 cases overall (36. 7%) (cad/cam vs. Conventional: 45. 9% vs. 33. 0%; p
0. 167). The location was the distal gap in 17 patients; there were eight isolated mesial non-unions and 22 patients had subtotal osseous union at more than one location. (figure 1) (b) panoramic view of subtotal osseous union in the right distal and intermediate gap (d) cone beam computed tomography of a subtotal osseous union in the right distal and right intermediate gap versus sufficient ossification in the left distal and left intermediate gap. Wound healing disorders at the recipient site occurred in 43 cases overall (33. 6%) (cad/cam vs. Conventional: 35. 1% vs. 33. 0%; p
0. 814). Nine cases (7. 0%) of fixation failure (cad/cam vs. Conventional 8. 1% vs. 6. 6%; p
0. 761). There were 28 cases (21. 9%) of plate exposure (cad/ cam vs. Conventional: 29. 7% vs. 18. 7%; p
0. 170) fixation failure (n
9) only occurred in patients with a 2. 0 mm plate. Plate failure only occurred with conventional plates. Screw loosening was found to be mechanisms of failure in the cad/cam group. Screw fracture was found to be mechanisms of failure in the cad/cam group. This report is for an unknown synthes mandible plates and screws. This complaint involves six (6) devices. This report is for (1) unk - plates: cmf. This report is 3 of 6 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester 19380
MDR Report Key10186860
MDR Text Key197110177
Report Number8030965-2020-04381
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
Type of Report Initial
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
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 Received06/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/23/2020 Patient Sequence Number: 1