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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: 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 (b)(6) 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) 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) 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) 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) 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) 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 3 of 6 (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: SCREW,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 Key: 10560699
• MDR Text Key: 209827349
• Report Number: 8030965-2020-07258
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• 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 Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR