MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RODS; PROSTHESIS, RIB REPLACEMENT

Device Problem Break (1069)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr rods/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Surgical/medical intervention.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: grzywna am.Et al (2016), offset layered closure reduces deep wound infection in early-onset scoliosis surgery, journal of pediatric orthopaedics b, volume 25, number 4, pages 361-368, (usa).The aim of this retrospective study was to compare deep infection rates in a single institution by a single surgeon before and after the institution of offset layered closure (olc) and attention to soft tissue handling for all early-onset scoliosis surgical cases.From january 1981 to december 2013, 158 patients who underwent distraction-based treatment for early-onset spinal deformity.There were 52 males and 76 females with a mean age at index surgery of 5.9 years (range, 11 months to 17 years).These patients underwent distraction-based surgery using a competitor¿s growing rod for 56 patients, an unknown synthes vertical expandable prosthetic titanium rib (veptr) for 62 patients and both devices were implanted for 10 patients.Both primary (index) procedures, as well as secondary procedures such as revisions or lengthenings, were included.A total of 1170 eos surgeries were included in the analysis, including 116 index surgeries and 789 lengthenings.Procedures were subdivided into 2 groups: those performed before january 2002 with standard closure (99 procedures) and those performed after january 2002 with offset layered closure (1071 procedures).By 2013, 58 out of 128 patients had completed growth-friendly treatment with a mean duration of 6.8 (+/-2.9) years.Of the 58 patients, 20 patients retained their devices and are being observed, 17 patients had the devices removed without formal fusion and 21 patients completed treatment with device removal and fusion, with no resultant infections.The authors did not specify which patients were implanted with the synthes device.Thus, complications will be reported as follows: 1 patient had partial wound dehiscence at 21 days after the index procedure.This was treated with dressing.1 patient had an implant prominence through the skin at 199 days after the implant exchange procedure.The patient was revised.1 patient had superficial wound drainage at 17 days after the index procedure.This was treated with antibiotic cream and dressing.1 patient had an unknown revision and had blistering at 6 days after the procedure.This was treated with dressing.1 patient had wound drainage at 62 days after the index procedure.This was treated with dressing.1 patient had fluctuance at 8 days after the lengthening procedure.This was treated with aspiration.1 patient had an implant prominence with eschar formation at 167 days after the lengthening procedure.This was treated with oral and topical antibiotics and dressing changes.A total of 7 patients had deep infections, 3 from the standard closure group and 4 from the offset layered closure group.These infections occurred at a mean of 1.1 years (range 26 days to 3.7 years) from the index surgery and a mean of 4.1 months (range 4 days to 7 months) after the previous surgical procedure.(standard closure group): 1 patient had a deep infection at 152 days after a lengthening procedure.The device was removed and the treatment was discontinued.1 patient had a deep infection at 18 days after the lengthening procedure.The device was partially retained and the treatment was continued.1 patient had a deep infection at 17 days after the index procedure.The device was removed and the treatment was discontinued.(offset layered closure group): 1 patient had a deep infection at 39 days after a revision due to a broken rod.The device was removed and the treatment was discontinued.1 patient had a deep infection at 13 days after the index procedure.The device was retained and the treatment was continued.1 patient had a deep infection at 152 days after a revision due to a broken rod.The device was partially retained and the treatment was discontinued.1 patient had a deep infection at 211 days after the index procedure.The device was retained and the treatment was continued.This is report 2 of 2 for (b)(4).This report is for unknown synthes (veptr) rods.

• Brand Name: UNK - RODS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• 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: 8775373
• MDR Text Key: 150547192
• Report Number: 2939274-2019-59092
• Device Sequence Number: 1
• Product Code: MDI
• 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: Physician
• Type of Report: Initial
• Report Date: 06/12/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/10/2019
• 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