MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SYNPOR IMPLANTS; MESH, SURGICAL

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k #: this report is for an unknown synpor implants/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: 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: park, a.And diaz, j.(2008), a different approach to orbital blow out fractures: microscope-assisted reconstruction of the orbital floor, international journal of pediatric otorhinolaryngology, vol.72, pages 707-710 (usa).This study presents a case report of a (b)(6)-year-old male patient who had left periorbital edema and a subconjunctival hemorrhage after being hit in the left cheek with a rock while rappelling.Ct imaging revealed a fracture of the left orbital floor with prolapse of fat into the maxillary sinus.A minimally displaced fracture of the orbital process of the frontal bone and a small epidural hematoma were also noted.Over the next month, however, he complained of progressively worsening diplopia on upper gaze.He was noted to have 3 mm of enophthalmos in the left eye.Repeat ct confirmed displacement of bony fragments along the orbital floor.He was treated with an 0.85 mm synpor (porous polyethylene) implant (synthes, inc., west chester, pa).Postoperatively, he did well.His upper gaze diplopia resolved.He had about 1.5 mm of enophthalmos relative to the right eye 4 months following surgery.He did experience transient midface hypoesthesia presumably from traction on the infraorbital nerve that resolved by 6 months following the procedure.His visual acuity and ocular pressures were normal throughout his postoperative course.This is report 1 of 2 for (b)(4).This is for a 0.85 mm synpor (porous polyethylene) implant (synthes, inc., west chester, pa).

• Brand Name: UNK - SYNPOR IMPLANTS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8887177
• MDR Text Key: 154266810
• Report Number: 2939274-2019-59739
• Device Sequence Number: 1
• Product Code: FTM
• 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: 07/17/2019

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: 07/17/2019
• Initial Date FDA Received: 08/13/2019
• 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: 14 YR