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

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/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.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.

Event Description

This report is being filed after the review of the following journal article: santolini, e.Et al.(2018), treatment of distal clavicle nonunion with and without bone grafting, injury, vol.49, sup.4, pages s34-s38 (italy).This study presents a case report of a (b)(6)-year-old female patient who presented left shoulder pain with exertion.Her past medical history included a polytrauma after a high energy road traffic accident in (b)(6) 2016, in which she sustained a lung contusion, spleen rupture, multiple rib fractures, left pubic rami fractures, and a left distal clavicle fracture (ao/ota 15.3c, neer type v).The distal clavicle fracture was treated conservatively in a sling, a plain radiograph of the left shoulder revealed a hypertrophic nonunion of the left distal clavicle.The nonunion was fixed with an lcp clavicle hook plate (depuy-synthes, west chester, pa, us).The following day, an x-ray of the left shoulder was obtained as part of protocol, but a new clavicle fracture at the medial end of plate was identified, without any reported injury suffered by the patient in between.The hook plate was removed.Locking plate fixation was performed with an anatomical lcp superior clavicle plate (depuy- synthes, west chester, pa, us) to address both the medial fracture and the distal nonunion.Her 6-month post-surgery follow-up visit revealed clinical improvements, demonstrating a full active range of motion and motor strength of the affected shoulder without any pain; radiographic images showed healing of both the medial fracture and the distal nonunion.This report is for an unknown synthes lcp clavicle hook plate.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 10711054
• MDR Text Key: 212288588
• Report Number: 8030965-2020-08076
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• 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: 09/28/2020
• 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: 62 YR