MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: SPINE-US; PLATE,FIXATION,BONE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Necrosis (1971); Impaired Healing (2378)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: xiaodong w., et al (2022) efficacy of laminoplasty and bone graft in the treatment of multilevel intraspinal tumor, development projects (y72017068) xxxx ,pages 1-10 (china).This study aims to explore the clinical effect of plate reduction and bone grafting in multi-section intravertebral canal tumour surgery.From june 2013 to may 2016, general data the clinical data of 35 patients , including 21 males and 14 females, aged 13 ¿ 65 years , with multilevel intraspinal tumors treated with vertebral plate reduction and bone grafting were analyzed.After tumor resection, the dura mater was watertight sutured.The removed spinous process vertebra is restored and elevated in situ.It is connected and fixed with the special titanium connecting piece for vertebral plate and 8 mm titanium screw (johnson & johnson, usa) on both sides of vertebral plate.Outpatient and telephone follow-up was performed, and complete spinal x-ray, ct and mri imaging examinations were required at least once 6 months after surgery until december 2017.All 35 patients were followed up for 8-36 months, with an average one of 14.2 months.The following complications were reported as follows: ip-01442327 unk - screws: spine-us and ip-01442227 unk - plates: spine-us.These impacted product captures these adverse events : there were 2 cases of poor incision healing after operation, of which 1 case had delayed incision healing after dressing change and microwave treatment, and the other case was complicated with deep muscle necrosis.The incision healed by second intention after debridement again.-one patient developed cerebrospinal fluid leakage and recovered after lumbar catheter drainage.The vertebral plate fusion rate was 84.5% only.This report is for unknown synthes spine vertebral plate and 8 mm titanium screw.This is report 2 of 2 for complaint.

Manufacturer Narrative

Additional narrative: 510k: this report is for unk - screws: spine-us 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.

• Brand Name: UNK - SCREWS: SPINE-US
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 14731455
• MDR Text Key: 295027150
• Report Number: 8030965-2022-04103
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• 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: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention