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

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: plate/screws/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.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.

Event Description

Device report from synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: yanagisawa y., et al (2020) delayed union of a surgically treated fragility fracture of the pelvis:a case report, international journal of surgery case reports volume 71, pages 230¿234 (japan).This study presents a case report of a patient of delayed union of type iiia ffp to inform the decision to undertake operative treatment for type iiia ffps.A case of a (b)(6) year old woman, 140 cm in height and 30 kg in weight, presented with a pelvic fracture due after falling from a standing height when getting out of the car.She was unable to walk and was transported to an adjacent hospital.Patient was transferred to another hospital for surgical treatment of ffp.Upon admission the patient was hemodynamically stable and moderately healthy with minor comorbidities (chronic gastritis, insomnia and osteoporosis).The patient was not taking any medication for osteoporosis at the time of injury as she did not want treatment.The diagnosis of type iiia ffps, displaced left ilium and left pubic rami fracture was made by x-ray and ct.Pre-operative blood tests revealed anemia (hemoglobin level, 8.2 g/dl).Bone mineral density of the femoral neck was 0.316g/cm2 and the young adult mean score was 40 %.Open reduction and internal fixation was performed 4 days after the injury using two reconstruction contoured plates (locking compression plate [lcp®] 3.5mm, synthes).The third bone fragment of iliac was not able to be fixed with the implant due to dislocation to the dorsal side from fracture site.Later, this site exhibited delayed union.The surgery time was 3 h and 10 min, and intraoperative blood loss was 200 ml.In the postoperative period, 560 ml of red cell concentrate was transfused due to anemia.The patient was transferred to the high-care unit for monitoring; intravenous hydration was withdrawn and oral food intake was allowed 6 h post-operatively.Weight bearing was not allowed for 6 weeks post-operatively, after which the patient was allowed to progress to full weight bearing.Evaluation of bone union by pelvic x-ray (anteroposterior, inlet and outlet view) was difficult because the plates, screws and fracture overlapped.Therefore, periodic ct examinations (post-operative 3, 5, 12 and 19 months) were performed to determine the progress of bone union.This revealed delayed union of the fracture.The patient experienced no pain waking with a walking stick and returned to most social activities including living independently within 6 months of the operation.The modified majeed score was 94 (except sexual intercourse, which was 4 points out of a possible 96) at 12 months post-operation.This report is for an unknown synthes reconstruction contoured plates (locking compression plate [lcp®] 3.5mm.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 11100336
• MDR Text Key: 228621770
• Report Number: 8030965-2020-10056
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 12/04/2020
• 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: 96 YR
• Patient Weight: 30