MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; DISPENSER, CEMENT

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

Patient Problems Necrosis (1971); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary 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, 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.(b)(4).

Event Description

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: siebenbürger, g.Et al (2019), screw-tip augmentation versus standard locked plating of displaced proximal humeral fractures: a retrospective comparative cohort study, journal of shoulder and elbow surgery, vol.28 (issue 7), pages 1-8 (germany).The aim of this retrospective study is to prove the safety of screw tip¿augmented locking plate osteosynthesis in displaced proximal humeral fractures and to compare the clinical and radiographic outcomes of screw tip¿augmented locking plate osteosynthesis vs.Locked plating only.Between january 2014 to august 2016, a total of 94 patients (75 females and 19 males) with a mean age of 77.5 ± 10.1 years were included in the study.Of the patients, 55 underwent fixation with a proximal humeral interlocking plate system (philos; depuy synthes, zuchwil, switzerland) and 39 underwent screw tip¿augmented locking plate osteosynthesis using philos and polymethyl methacrylate (pmma traumacem v+; depuy synthes).All patients were followed up from the time of the operation until 2 years of follow-up.The following complications were reported as follows: locking plate only 3 patients had avascular necrosis despite stable fixation.4 patients underwent revision surgery.4 patients had chondral penetration which was noted before augmentation (positive dye leak test), resulting in aborting the augmentation procedure.6 patients had loss in fixation, in which 2 patients had screw cut-out.Screw tip¿augmented locking plate 2 patients had loss in fixation.3 patients had avascular necrosis despite stable fixation.2 patients underwent revision surgery.A (b)(6)-year-old female patient had prolonged fracture consolidation after screw tip augmentation and partial avascular necrosis surrounding augmented humeral head screws noted 6 months after surgery.This report is for an unknown synthes plates, unknown synthes screws and unknown synthes traumacem.These impacted products capture the reported (b)(6)-year-old female patient who had a prolonged fracture consolidation and partial avascular necrosis.This report is for one (1) unknown biomaterial - cement: traumacem.This report is 10 of 10 for (b)(4).

• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8899429
• MDR Text Key: 154536816
• Report Number: 8030965-2019-67316
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2019
• 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