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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS 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 Arthritis (1723); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for anunk - constructs: plate/screws/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.
 
Event Description
Device report from austria reports an event as follows: this report is being filed after the review of the following journal article: gregori m, et al. (2019), preserving the radial head in comminuted mason type iii fractures without fixation to the radial shaft: a mid-term clinical and radiographic follow-up study, journal of shoulder and elbow surgery, volume 28, page 2215-2224, (austria). The purpose of this retrospective case-control study was to determine the clinical short- and mid-term outcomes of radial head salvage procedure in comminuted radial head fractures irrespective of concomitant injuries, and to identify late-onset sequelae. Between 2005 and 2015, 30 patients with multi fragment mason type iii fractures of the radial head were included in the study. 29 of these patients received a biological radial head spacer (group s) while 12 were treated by open reduction and internal fixation using low-profile mini-fragment plates (group p). In group s, 3 patients who had other surgery were implanted with an unknown synthes 6-hole anatomic 2. 7-/3. 5-mm locking olecranon plate, and 1 patient was implanted with an unknown synthes 8-hole locking compression plate in the ulna. Meanwhile, in group p, 1 patient who had other surgery was implanted with an unknown synthes 6-hole anatomic 2. 7-/3. 5-mm locking olecranon plate. All patients are immobilized using an upper arm splint with elbow flexion of 90 degrees until wounds are healed. The period of immobilization depends on the severity of concomitant injuries. Return to arm-demanding sports and heavy manual work is permitted at 12 weeks postoperatively. Complications were reported as follows: 4 patients had partial radial nerve palsies: 2 occurred postoperatively, and the other 2 occurred as part of the primary injury. (group s). 14 patients had nonunion developed at the head-neck junction. Case 16, a (b)(6) year old patient had grade 2a heterotopic ossification, grade 2 radio capitellar osteoarthritis, and grade 2 glenohumeral osteoarthritis during follow-up at 4. 9 years. Case 18, a (b)(6) year old patient had grade 1 heterotopic ossification, grade 1 radio capitellar osteoarthritis, and grade 1 glenohumeral osteoarthritis during follow-up at 7. 6 years. Case 19, a (b)(6) year old patient had grade 2c heterotopic ossification, grade 3 radiocapitellar osteoarthritis, and grade 2 ulnohumeral osteoarthritis during follow-up at 7 years. Revision 1, a (b)(6) year old patient was revised to a bipolar prosthesis. At 8 months after primary surgery, the patient still complained about painful restriction of elbow motion consisting of a 40 degrees pronation deficit and total sagittal motion of 100 degrees with an extension deficit of 20 degrees. Following radial head resection and radial head arthroplasty, pain decreased but slight pain during manual work was still present. This patient had grade 2c heterotopic ossification, grade 2 radiocapitellar osteoarthritis, and grade 2 ulnohumeral osteoarthritis during follow-up at 10. 5 years. (group p). Case 27, a (b)(6) year old patient had grade 2a heterotopic ossification, grade 1 radiocapitellar osteoarthritis, and grade 2 ulnohumeral osteoarthritis during follow-up at 6. 9 years. This report is for the unknown synthes 6-hole anatomic 2. 7-/3. 5-mm locking olecranon plate, unknown synthes 8-hole locking compression plate and unknown synthes screws. This is report 2 of 6 (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10560700
MDR Text Key207752723
Report Number8030965-2020-07255
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
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 Received09/01/2020
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: 09/21/2020 Patient Sequence Number: 1
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