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

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Ulcer (2274); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

39 patients (13 males and 26 females with a mean age of 63 years) 510k: this report is for an unknown synthes 2.7 var dorsal fusion 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.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 filed after the review of the following journal article: wanivenhaus f.Et al (2017), quality of early union after first metatarsophalangeal joint arthrodesis.The journal of foot & ankle surgery.Volume 56, pages 50-53 (switzerland).The objectives of this retrospective group study were to assess the fusion rate of patients who had undergone first metatarsophalangeal joint (mtpj) arthrodesis using a dorsal fusion plate combined with a plantar lag screw 6 weeks after surgery through ct scans; also, to evaluate the clinical outcomes and complication rates after a minimum of 1 year follow-up.From march 1, 2011 to december 31, 2012, 39 patients (13 males and 26 females with a mean age of 63 years) were included in the study.These patients were implanted with an unknown synthes 2.7-mm variable angle metatarsophalangeal fusion plate and with a competitor plantar lag screw.Fusion was measured into two categories; partial fusion or total fusion.The mean follow-up period was 22.8 months (range 12.4 to 55.3).Complications were reported as follows: 2 patients were not satisfied with their postoperative outcome.25 patients had partial bone union.Ct analysis showed a mean joint bridging of 59.0% +/- 16.6%.3 patients had no signs of bone union.Ct analysis showed a mean joint bridging of 27.0% +/- 5.8%.At the last follow-up, 3 patients have a partially fused joint.For the 3 cases rated as partially fused, the patients reported no pain and demonstrated a mean joint bridging of 40% +/- 10% at 6 weeks postoperatively.7 cases had hardware removal because it was painful.1 patient had revision arthrodesis was performed due to nonunion.This patient had parkinson¿s disease.1 patient developed an ulcer dorsal to the plate.This patient was taking immunosuppressant drugs for rheumatoid arthritis and developed an infected nonunion.The hardware was removed.1 patient demonstrated delayed union and underwent revision arthrodesis.The patient was not compliant and had decided to mobilize in normal footwear instead the postoperative shoe provided.This report is for an unknown synthes 2.7 var dorsal fusion plate this report is 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: PLATE, FIXATION, BONE
• 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: 7772273
• MDR Text Key: 116781010
• Report Number: 8030965-2018-55615
• Device Sequence Number: 1
• Product Code: HRS
• 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: Physician
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• 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: 07/23/2018
• 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