MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE,FIXATION,BONE

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown plate.Pma/510(k) number is not available.Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: acevedo, d.Et al (2013), mixing implants of differing metallic composition in the treatment of upper extremity fractures, orthopedics, pages e1179 - e1179 (usa).The purpose of this study was to evaluate upper-extremity fractures treated with open reduction and internal fixation (orif) using implants of differing metallic composition in close contact with each other on the same bone to determine whether this technique is safe and whether clinically significant complications occur.Between january 2002 and october 2009, a total of 17 patients was included in this study.The study group comprised 11 men and 6 women with a total of 8 clavicle, 3 olecranon, 3 distal humeri, and 2 proximal humeri fractures and 1 glenoid fracture.Thirteen patients had acute fractures of the upper extremity treated by orif using standard approaches for the fracture types.The remaining 4 patients had subacute clavicle fractures that were impending nonunions.Each patient had the combination of stainless steel and titanium plates placed in close proximity on the same bone.These plates were stainless steel mini-locking plates (modular mini lcp system; synthes, paoli, pennsylvania), and the titanium plates were pre-contoured anatomic plates for the upper extremity (acumed plating system; acumed, hillsboro, oregon, and s3 proximal humerus plate; depuy, warsaw, indiana).Bone morphogenetic protein was used to supplement healing in 11 patients, and demineralized bone matrix was used in 2 patients.All patients were followed until clinical and radiographic union was achieved.Operative reports, radiographs, and clinical notes were reviewed.The following complications were reported as follows: patient 3 - (b)(6) year-old had superficial wound infection treated with antibiotics.Patient 6 - (b)(6) year-old had screw backout.Patient 7 - (b)(6) year-old had brachial plexitis and lymphedema due to breast cancer and lymph node dissection and radiation.Patient 14 - (b)(6) year-old had postoperative radial nerve palsy (transient radial nerve neuropraxia).Patient 16 - (b)(6) year-old had superficial wound infection and underwent open release, hardware removal, and heterotopic bone resection.Unknown 1 patient had unresolved ulnar nerve palsy.This patient had a distal humerus fracture that underwent orif with an ulnar nerve transposition.This report is for an unknown mini-locking plates (modular mini lcp system).It captures the complications in an unknown 1 patient had unresolved ulnar nerve palsy.This patient had a distal humerus fracture that underwent orif with an ulnar nerve transposition.This is report 5 of 7 for (b)(4).

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8298696
• MDR Text Key: 134859550
• Report Number: 2939274-2019-56259
• Device Sequence Number: 1
• Product Code: HRS
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• 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: 01/16/2019
• 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