MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: CANNULATED; SCREW,FIXATION,BONE

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown screws: cannulated/unknown lot.Part and lot numbers 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.(b)(4).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: mittlmeier, t.And eschler, a.(2015), corrective arthrodesis of midfoot charcot neuroosteoarthropathy with internal implants, surgical orthopedics and traumatology, vol.27 (2), pages 139-153, doi 10.1007/s00064-014-0338-8 (germany).The objective of the two retrospective studies is to present the goal of treatment in diabetic neuropathic osteoarthropathy (dnoap) which is a plantigrade, stable, foot free of ulcers over the long term that can be treated with orthopedic shoe modification using diabetes-adapted insoles.Two retrospective studies on correctional arthrodesis in noap with internal implants in the tarsal area were conducted in 2012 and 2013.The former, included 37 feet of 31 patients (age 55.7 years, range 29 72 years).All patients, except one, were diabetics.Surgical outcome was evaluated on average of 4.5 years (range 2-12 years) postoperatively.The second study included patients (56 years, range 47-68 years, follow-up 2.3 years) who underwent isolated arthrodesis of the medial toe column using only a single intramedullary bolt (mfb).Plantar plate position or intramedullary (e.G., midfoot fusion bolt) and extramedullary (preferably, angular stable locking plates) implant combinations were utilized to maximize primary stability (superconstruct) of the medial and/or lateral foot columns.The lateral foot column was created after cartilage removal from the calcaneocuboid joint using a retrograde cannulated 7.3-mm tension screw (depuy synthes, (b)(4)).The first study reported implant associated complications in 68% of patients (19% of which exhibited signs of loosening).The second study noted moderate implant-associated complication rate (2 instances of implant loosening).The authors concluded that for a long-term stable reconstruction of noap-affected midfoot, internal fixation techniques require procedures with very high primary stability (superconstruct), be employed.If the patient has a high-risk profile, the use of external fixation techniques should be considered.Patient(s) info: angular stable plates (e.G., 3.5 mm lcp, 2.4 mm/27 mm va lcp and locking mesh plate, depuy synthes, (b)(4), midfoot fusion bolt 6.5 mm (depuy synthes, (b)(4)), cannulated screws 7.3 mm (depuy synthes, (b)(4)).N=? (68% of patients) - implant associated complications, n=? (19% of patients) - loosening.Midfoot fusion bolt 6.5 mm (depuy synthes, (b)(4)) n=2 - loosening.Treatment noted: treatment for both studies there were no specific treatments for implant associated complications and loosening.This report is for an unknown synthes plate and screws construct, unknown synthes midfoot fusion bolt and unknown cannulated screws.This report is for one (1) unknown - screws: cannulated.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - SCREWS: CANNULATED
• Type of Device: SCREW,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: 9402937
• MDR Text Key: 185685035
• Report Number: 8030965-2019-70696
• Device Sequence Number: 1
• Product Code: HWC
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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: 11/11/2019
• 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