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 Neuropathy (1983); Pain (1994); No Code Available (3191)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

Multiple patient.Implantation date unknown.This report is for an unk - constructs: plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 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 korea, south as follows: this report is being filed after the review of the following journal article: jung, h.S., chun, k.J., kim, j.Y.And lee, j.S.(2020), necessity of acceptable radiologic alignment by preoperative closed reduction for unstable distal radius fractures treated with volar locking plates, european journal of trauma and emergency surgery, pages 1-7 (south korea).The purpose of this study was to demonstrate the necessity of achieving acceptable radiographic alignment by preoperative closed reduction in unstable distal radius fractures (drfs) to improve preoperative pain and obtain satisfactory outcomes after surgery.From 2013 to 2016, 239 patients included 53 men and 186 women with a mean age of 60.78 ± 13.85 years (range, 20¿95 years) were treated with volar locking plates for drfs.Of the 239 patients, 80 had non-acceptable and 159 had acceptable reductions.Among these patients, 201 (66 in group a vs.135 in group b) were matched in a 1:2 matched ratio.Implants used were a volar locking plate (variable angle lcp, depuy synthes, paoli, pa, usa; or dvr, biomet, miami, florida, usa).Patients were followed up at approximately 6 weeks, 3 months, and 6 months and at 1-year intervals.The article did not specify which of the devices were being used to capture the following complications: 80 patients had non-acceptable reduction.Group a.5 patients had early complications.4 patients had superficial infection.1 patient had type i crps.2 patients had late complications.1 patient had median nerve neuropathy.1 patient had hardware related tendon irritation.Group b.9 patients had early complications.1 patient had wound dehiscence.5 patients had superficial infection.3 patients had type i crps.2 patients had late complications.2 patients had median nerve neuropathy.This report is for an unknown synthes volar locking plate (variable angle lcp, depuy synthes, paoli, pa, usa).

• 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: 10420691
• MDR Text Key: 210501268
• Report Number: 8030965-2020-06077
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention