MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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

Patient Problems Arthritis (1723); Irritation (1941); Pain (1994); Local Reaction (2035); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes 3.5 mm locking compression t-plate/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.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: wingea, mi.And røkkuma, m.(2018), cap cement is equivalent to iliac bone graft in filling of large metaphyseal defects: 2 year prospective randomised study on distal radius osteotomies, injury, international journal of the care of the injured, vol.49(3), pages 636-643 (norway).The purpose of this prospective randomized study is to compare the clinical and radiological outcomes of injectable cap bone cement with corticocancellous bone graft used to fill voids after corrective opening wedge osteotomies in the distal radius.Between january 2007 and may 2009, a total of 20 consecutive patients underwent an open-wedge osteotomy of a dorsal malunion in the distal radius randomized to filling the defect either with bone graft consisted of 10 patients (2 male and 8 female) with a mean age of 57 years (range, 45.5; 61.5 years) or unknown synthes cap bone cement consisted of 10 patients (1 male and 9 female) with a mean age of 56 years (range, 55.0; 60.5 years).A titanium alloy lcp t-plate, 3.5 mm oblique-angled, (synthes gmbh, solothurn, switzerland) was bent to fit the distal radius and fixed with angle locking screws.Follow-up was done in 24 months.The following complications were reported as follow: a (b)(6) year-old female patient, resorption and initial bone bridging along the surface of cap cement was observed in this patient.This patient also experienced a plate fracture.1 cap cement patient experienced dorsal tenderness from 4 months post-operatively, before she sustained a minor injury while making the bed 2 months later resulting in ulnar pain.7 cap bone cement patients had plate removals done between 1 and 2 years due to local irritation from the plate and tenosynovitis-like symptoms.Some soft-tissuereaction was found around the plate and along the tendons in the areas of mechanical contact with the plate.1 cap bone cement patient was operated just after 2 years with triscaphoid fusion for osteoarthritis.1 bone graft patient with some continuous wrist pain developed a pseudoarthrosis in the proximal junction.2 bone graft patients had insufficient bone healing.2 patients with bone grafts suffered epl tendon ruptures at the distal edge of the plate 2 and 5 months post-operatively and needed indicis proprius transfers.The first patient also developed a pseudoarthrosis and underwent simultaneous bone grafting.The second patient had a healed osteotomy and plate removal was combined with tendon transfer.5 bone graft patients had plate removals done between 1 and 2 years due to local irritation from the plate and tenosynovitis-like symptoms.Some soft-tissue reaction was found around the plate and along the tendons in the areas of mechanical contact with the plate.Hip pain was only noted at 2 weeks in the bone graft group.Unknown cap cement patient had plate fracture.This report is for the following adverse events: local irritation from the plate and tenosynovitis-like dorsal tenderness, osteoarthritis, wrist pain , pseudoarthrosis in the proximal junction, insufficient bone healing, epl tendon ruptures, hip pain.This report is for an unknown synthes 3.5 mm locking compression t-plate.This is report 3 of 4 for (b)(4).

• 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: 8316593
• MDR Text Key: 135505651
• Report Number: 8030965-2019-60735
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/19/2019
• Initial Date FDA Received: 02/07/2019
• 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