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

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

Patient Problems Pain (1994); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown plate/screws construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between february 2011 to march 2015.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.(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

This report is being filed after the review of the following journal article: ellwein, a.Et al (2019), clinical evaluation of double-plate osteosynthesis for olecranon fractures: a retrospective case-control study, orthopaedics & traumatology: surgery & research, vol.105 (8), pages 1601-1606 (germany).The aim of this retrospective study is to present the surgical technique using this novel double-plate implant and compare functional results (range of motion, patient related outcome scores), complications rates and revision surgeries to a common single, dorsal locking plate osteosynthesis.Between february 2011 to march 2015, a total of 47 patients (24 male and 23 female) with a mean age of 59 ± 19 years (range: 18¿93) underwent open reduction and internal fixation.Surgery was performed using a 3.5 mm olecranon locking compression plate (lcp) (fa.Depuy synthes, umkirchen, germany) in 22 patients or olecranon low-profile double-plate from a competitor in 25 patients.The mean follow-up was 41 months (range: 25-61).The following complications were reported as follows: 4 patients had died due to unrelated causes.8 patients underwent an overall nine revision surgeries.The remaining eight revision surgeries (36%) were implant removals and were performed on average 15 ± 4 months (range: 8¿21) after implantation.The implant was described as disturbing by all eight patients.All patients reported improvement after implant removal.5 patients (23%) had an extension deficit of at least 10° compared with the contralateral elbow.2 patients were unsatisfied with their result (9%); 1 because of a persisting moderate pain level (4 out of 10) and one because of severe limitations of elbow motion (extension/flexion: 0¿50¿90°).A 45-year-old patient reported persisting intraarticular friction.An additional ct-scan revealed an intraarticular screw, which was substituted with a shorter screw.This report is for an unknown synthes plate/screws constructs and unknown synthes screws.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown plate/screws construct.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10515621
• MDR Text Key: 214747758
• Report Number: 8030965-2020-06778
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 08/14/2020
• 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