MAUDE Adverse Event Report: SYNTHES GMBH UNK - RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is for an unk - 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.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.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 (b)(6) as follows: this report is being filed after the review of the following journal article: yeh, k.T.Et al (2020), two surgical strategies for treating multilevel cervical spondylotic myelopathy combined with kyphotic deformity, medicine, vol.99 (7; e19215), pages 1-7 (taiwan).The aim of this retrospective study is to present the surgical results of the two different operation strategies for patients who were diagnosed as having mcsm combined with ckd.Between january 2013 to december 2017, a total of 105 patients (54 male and 51 female) with a mean age of 64.5±11.9 years were included in the study.Of these, 63 patients underwent elta, and 42 patients underwent lapi.The elta method involved c3-6 eolp secured with miniplates (synthes, mi) and a c7 partial laminectomy followed by c3-6 or c4-7 acdfs with titanium cages.The lapi method involved applying acdfs (>3 segments) with polyetheretherketone (peek) cages, c2-7 or c3-7 pif with lateral mass or a pedicle screw-rod system (synthes spine, westchester, pa), and pd through laminoplasty secured by miniplates (synthes, mi).The minimum follow-up period was 1 year.The following complications were reported: an unknown number of patients had loss of correction at postoperative year 1 was <5° in both groups.All 105 patients had mild to moderate dysphagia 2 weeks post-surgery, which persisted in 35 (33.3%) patients 2 to 6 weeks post-surgery: 25 of such patients were in the elta group (39.7%) and 10 were in the lapi group (23.8%).7 patients had poor posterior side wound healing and required surgical debridement and repair: 4 were in the elta group (6.3%) and the 3 were in the lapi group (7.1%).This report is for an unknown synthes laminoplasty miniplates/screws constructs, unknown synthes mono/polyaxial screws, and unknown synthes rods.This report is for (1)unk - rods this report is 1 of 3 for (b)(4).

• Brand Name: UNK - RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 12452948
• MDR Text Key: 270808281
• Report Number: 8030965-2021-07627
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: 08/12/2021
• 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