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 Loss of Range of Motion (2032); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown hook locking compression plates/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review /investigation.(b)(4).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: seo, j.B., kim, s.J., ham, h.J., and yoo, j.S.(2020), comparison between hook plate fixation with and without coracoclavicular ligament suture for acute acromioclavicular joint dislocations, journal of orthopaedic surgery, vol.28(1), pages 1-7 (south korea), https://doi.Org/10.1177/2309499020905058.The purpose of this study was to evaluate the outcomes of the hook plate fixation with direct coracoclavicular (cc) ligament repair for acute acromioclavicular joint (acj) dislocation in comparison with the hook plate fixation without direct cc ligament repair.From january 2011 to december 2017, a total of 120 patients (17 females and 103 males) with an age range of 19-72 years underwent open reduction and internal fixation with the conventional ao hook locking compression plate (lcp; synthes, solothurn, switzerland) for rockwood types iii¿vi acj dislocations.The implant was removed after 3¿5 months.The following complications were reported as follows: 81 patients had postoperative stiffness although pendulum and self-assisted circumduction exercises were started 3 days after surgery.Brisement or arthroscopic capsulectomy was performed in patients with postoperative stiffness during implant removal.After implant removal, all patients recovered full rom at the final follow-up.51 patients was observed to had subacromial erosion.28 patients had post-traumatic acj arthrosis.This report is for an unknown synthes ao hook locking compression plate.This is report 1 of 1 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: 10742377
• MDR Text Key: 216645280
• Report Number: 8030965-2020-08225
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 09/29/2020
• 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