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

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes proximal humeral internal locking system (philos) plate/unknown lot.Part and lot number 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: moonot p, ashwood n, hamlet m (2007)."early results for treatment of three- and four-part fractures of the proximal humerus using the philos plate system." the journal of bone & joint surgery.Volume 89-b.No.9.Page 1206-1209 (united kingdom).This prospective study was undertaken to evaluate the efficacy of the proximal humeral internal locking system (philos) plate in the treatment of displaced three- and four-part fractures of the proximal humerus.Between january 2003 and december 2005, a total of 32 patients with displaced 3 and 4 part fractures of the proximal humerus had an open reduction with internal fixation using a philos plate.There were 9 mine and 23 women with a mean age of 59.9 years (range, 18 to 87).All patient were implanted with an unknown synthes proximal humeral internal locking system (philos) plate and a minimum of 4 unknowns synthes proximal locking screws.Unknown ao cortical screws were also used to hold the plate on the humeral shaft.Patients with severely osteoporotic bones were implanted with the locking screws.2 patients with poor bone stock received a bone substitute from competitor¿s company.Post-operatively the arm was supported in a sling.Pendular movements were started from the first postoperative day and the shoulder was mobilized with active assisted exercises, followed after 3 weeks by active exercises.All the patients were seen at 2 and 6 weeks and at 3-month intervals until the union was achieved.Assessment of shoulder function was by the constant score.The mean follow-up was for 11 months (3 to 24).Complications were reported as follows: a (b)(6) patient with a 3-part fracture had symptoms of impingement requiring removal of the plate.This report is for an unknown synthes proximal humeral internal locking system (philos) plate.Additional complications are reported on related complaint (b)(4).This is report 6 of 9 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8226788
• MDR Text Key: 132379277
• Report Number: 8030965-2019-59571
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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: 12/13/2018

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: 12/13/2018
• Initial Date FDA Received: 01/08/2019
• 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
• Patient Age: 40 YR