MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.This report is for unknown biomaterial preformed: chronos: trauma.Part and lot numbers are unknown.Without the specific part and lot number; the udi number is not available.Complainant device is not expected to be returned for manufacturer review/investigation.The (510k#): unknown.Reporter phone number is not provided for reporting.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

This report is being filled after the subsequent review of the following literature article hanke a., baumlein m., lang s., gueorguiev b., nerlich m., perren t., rillmann p., ryf c., miclau t., loibl m.(2017).Long-term radiographic appearance of calcium-phosphate synthetic bone graft after surgical treatment of tibial plateau fractures.Injury, int.J.Care injured.48:2807-2813.(b)(6).The purpose of this study to assess the long-term resorbtion of two different cap synthetic bone graft products used for operative treatment of treatment of tibial plateau fractures by comparing their radiographic visibility in a long-term follow-up.The study included 38 patients, 21 females and 17 males, all with intraarticular tibial plateau fractures.Nineteen (19) of the patients were inserted with sbg type a (chronos inject, depuy synthes, (b)(4)), and the remaining nineteen (19) were inserted with sbg type b (norian srs, depuy synthes, (b)(4)).Two patients (one with the sbg a and the other with sbg b) experienced early wound infections in the first month following the surgery.The hardware was not removed in either case.Twenty-nine (29%) percent of the patients with sbg b experienced no resorbtion (resorbtion of the sbg is a needed part of the healing process), 17.5% experienced more than 50% resorbtion, 52.6% experienced less than 50% resorption.No patient with the sbg b experienced complete resorbtion.Of the patients inserted with sbg a 21.1% experienced more than 50% resorbed and 7.0% experienced less than 50% resorbed.The remaining 71.9% experienced complete resorbtion.Four patients ( 2 in the sbg a group and 2 in the sbg b group) had a subsidence greater than 2 mm.One patient declared moderate pain and reduced knee scores.Three patients were asymptomatic.Four (4) patients who experienced a subsidence greater than 2 mm were: 1 female patient (b)(6) (sbg a), 1 female patient (b)(6) (sbg a), 1 female patient (b)(6) (sbg b), 1 male patient (b)(6) (sbg b).This report is for a one (1) (b)(6) female patient with sbg a, who experienced pain and subsidence greater than 2 mm following the surgery.This report is for unknown biomaterial preformed: chronos: trauma.This is report 5 of 8 for complaint (b)(4).

• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7252163
• MDR Text Key: 99363042
• Report Number: 8030965-2018-50948
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR