MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Joint Contracture (4528)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: lcp/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.

Event Description

Device report from synthes reports an event in korea, south as follows: this report is being filed after the review of the following journal article: park k.H., et al (2021) matched case¿control comparison of bone transport using external fixator over a nail versus external fixator over a plate for segmental tibial bone defect, journal of orthopedic trauma volume xxxx, pages 1-22 , journal of orthopedic trauma volume xxxx, pages 1-22 (korea, south).This retrospective matched case¿control study aims to compare hybrid techniques in a uniform group of patients (with segmental tibial bone defects >4 cm).Between 2003 and 2015, all patients presenting to our tertiary referral hospital with segmental tibial defects requiring bony reconstruction who underwent either bone transport over a nail (bton) or bone transport over a plate (btop) were considered for this study.The patients were divided into two groups: the bton and btop groups.Among the 19 identified patients who had been treated using the bton technique between 2003 and 2011, one was lost to follow-up, leaving 18 patients (16 males and 2 females) age 47 (range 18-78 years) in this group.Among the 18 patients in the bton group, nine (8 males and 1 female) age 54 (range 43-78 years) were treated with the bton (¿plate) technique between 2003 and 2007, whereas the other nine patients (8 males and 1 female) age 40 (range 18-62 years ) were treated with the bton (+plate) technique.Between 2008 and 2017, 32 patients were treated with btop; however, among them, four had insufficient follow-up data to warrant inclusion, and another three patients were excluded because they had <4-cm bony defects of the tibia, leaving 25 patients in the btop study cohort.Among the 25 patients, 18 patients (15 males and 3 females) age (b)(6) ( range 19-84 years ) were directly matched against corresponding patients from the bton group.In the btop group, after choosing an adequate size and type of plate (locking compression plate; depuy synthes, zuchwil, switzerland), it was fixed to span the defect.A circular ring ef (n = 4 patients) or unilateral ef (orthofix; stryker, rome, italy) (n = 14 patients) was fixed as a transport frame.The mean follow-up period was 100.5 months (range, 24¿252 months) in the bton group and 64.9 months (range, 24¿168 months) in the btop group.3 patients suffered transient flexion contracture of the knee or ankle, which required physical therapy.One patient in the btop group developed claw toes, which required tendon release.In the btop group, one patient suffered a deep distraction site infection during the consolidation period, resulting in bone reconstruction failure.The induced membrane technique was performed to reconstruct the segmental bone defect.1 non-union.1 osteomyelitis.A case of a (b)(6) year-old man who underwent btop had a residual 2.5-cm leg discrepancy.This report is for an unknown synthes locking compression plate.This report is for (1)unk - constructs: lcp.This report is 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12586450
• MDR Text Key: 276859424
• Report Number: 8030965-2021-08449
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/09/2021

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: 09/09/2021
• Initial Date FDA Received: 10/06/2021
• 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