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 Skin Irritation (2076); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown plate/screws construct/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.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: ochen, y.Et al (2019), surgical treatment of neer type ii and type v lateral clavicular fractures: comparison of hook plate versus superior plate with lateral extension: a retrospective cohort study, european journal of orthopaedic surgery & traumatology, vol.29 (xx), pages 989¿997 (netherlands).The aim of this dual-center retrospective cohort study is to evaluate patients treated with chp and scple fixation by comparing patient-reported functional outcome, complication-, and implant removal rates.Between january 2011 to june 2016, a total of 76 patients were treated with open reduction and internal fixation (orif).Surgery was performed using a chp (3.5 mm lcp; depuy synthes gmbh, oberdorf, switzerland) in 23 patients, or scple (3.5/2.7 mm lcp; depuy synthes gmbh, oberdorf, switzerland) in 53 patients.A total of 67 patients (88%) with a mean age of 43 (14) were available for the final follow-up, 19 patients (13 male and 6 female) in chp group, and 48 patients (41 male and 7 female) in scple group.Follow-up visits were scheduled at 2, 4, and 12 weeks postoperatively.The mean follow-up was at 31.3 (16.3) and 40.0 (18.0) months for chp and scple, respectively.The following complications were reported as follows: chp group: 1 patient had implant failure due to implant displacement.1 patient had nonunion and underwent revision surgery.19 patients underwent implant removal due to irritation (n=16) and per patients¿ request without irritation or routinely done (n=3).Scple group: 2 patients had implant failure due to implant displacements.1 of these underwent revision surgery.1 patient had implant failure due to screw breakage.1 patient had nonunion and underwent revision surgery.20 patients underwent implant removal due to irritation (n=15) and per patients¿ request without irritation or routinely done (n=5).Of the patients who did not undergo removal, 6 patients had irritation but implant removal is not necessary, 5 patients had irritation but no request for removal due to fear of reoperation, and 5 patients had irritation and considering removal.This is report 10 of 10 for (b)(4).This report is for an unknown synthes plate/screws constructs and unknown synthes screws.

• 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: 10627351
• MDR Text Key: 209825688
• Report Number: 8030965-2020-07707
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: 09/25/2020
• 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