MAUDE Adverse Event Report: SYNTHES USA; PLATE, FIXATION, BONE

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Strauss, e., tejwani, n., preston, c.And egol, k.(2006).The posterior monteggia lesion with associated ulnohumeral instability.J bone joint surg (br), 88-b, 84-89.This report is for an unknown 12 hole dynamic compression plate/unknown quantity/unknown lot.(other number) udi: unknown part number, udi is unavailable.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following literature article, strauss, e., tejwani, n., preston, c.And egol, k.(2006).The posterior monteggia lesion with associated ulnohumeral instability.J bone joint surg (br), 88-b, 84-89.The authors conducted at retrospective study to compare the clinical, radiographic and functional outcomes of patients with a monteggia lesion, characterized as a fracture of the proximal ulna distal to the end of the olecranon process, with an associated dislocation of the radiocapitellar joint and those patients without an associated dislocation.Initial ulnar fractures were treated with synthes small fragment plates and those of competitor.Between july 1997 and june 2003, 28 patients were identified, with a subsequent 23 available for follow-up.Four men and two women with a mean age of 47 years (range, 23 to 87 years) had an accompanying posterior ulnohumeral dislocation at the time of injury.Mean follow-up for these patients was 28 months (range, 14 to 48 months).Twelve women and five men, with a mean age of 55 years (range, 18 to 83 years) and a mean follow-up of 29 months (range, 12 to 60 months) did not sustain an associated dislocation.Results for patients with an associated dislocation of the radiocapitellar joint included: case 6 a (b)(6) male who underwent proximal ulnar fixation with a 12 hole dynamic compression plate and radial head fixation with a mini t plate.X-ray showed non-union of the ulna after nine months with bending of the plate.The patient underwent bone grafting and revision plating.A copy of the literature article is being submitted with this medwatch.This is report 2 of 3 for (b)(4).This report is for an unknown 12 hole dynamic compression plate.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5417501
• MDR Text Key: 37714539
• Report Number: 2520274-2016-10876
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• 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: 32 YR