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 Muscular Rigidity (1968); Nerve Damage (1979); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 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.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.(b)(4).

Event Description

Device report from synthes reports an event in spain as follows: this report is being filed after the review of the following journal article: garcia-cepeda, i.Et al (2020), radiological results of surgical management of fracture of the distal radius treated with volar locking plates, injury, vol.51, supplement 1, pages 542-547 (spain).The objective of this study is to assess functional and radiological results of all distal radius fractures treated with open reduction and internal fixation with a volar locking plate.The aim of the study includes the comparison of the functional results (based on range of motion), surgery tim- ing, fracture/patient characteristics and postoperative radiological parameters.Between january 2010 ti june 2018, a total of 170 patients with a mean age of 55.9 years underwent open reduction and internal fixation.The implants used were a variable angle lcp volar rim distal radius plate®(depuy-synthes, synthes gmbh, oberdorf, switzerland) for 5 cases, a variable angle lcp two-column volar distal radius plate®(depuy-synthes, synthes gmbh, oberdorf, switzerland) for 107 cases, an acu-loc 2 vdr®(acumed llc, hillsboro, oregon, usa) for 50 cases, and a dvr crossloc plate (biomet ortho- pedics, warsaw, indiana, usa) for 8 cases.The article did not specify which of the devices were being used to capture the following complications: patients below 60 years old had 0.1% fair and 0.1% poor results.Patients above 60 years old had 10.52% fair and 3.9% poor results.11 patients had complex regional pain syndrome.10 patients had intra-articular screw penetration.5 patients had tendinous rupture.3 patients had a rupture of extensor pollicus longus.2 patients had a rupture of the extensor digitorum of the 2nd finger.5 patients had painful or hypertrophic scars.3 patients had painful ulnar impingement.1 patient had pain related to osteosynthesis hardware.1 patient had stiffness.1 patient had ulnar nerve compression.18 patients needed a new surgery.11 patients had hardware removal.4 patients had tendinous disruptions repairs or transfers.1 patient had new osteosynthesis.Patients undergoing reintervention had worse functional outcomes with a decreased range of motion in flexion-extension.2 patients had a fair result for palmar tint.31 patients had a poor result for palmar tint.9 patients had fair results for radial inclination.4 patients had poor results for radial inclination.This report is for an unknown synthes variable angle lcp volar rim distal radius plate®(depuy-synthes, synthes gmbh, oberdorf, switzerland) and a variable angle lcp two-column volar distal radius plate®(depuy-synthes, synthes gmbh, oberdorf, switzerland).This is report 1 of 3 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10346889
• MDR Text Key: 209136641
• Report Number: 8030965-2020-05506
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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: 07/30/2020
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention