MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS; SCREW,FIXATION,BONE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Dysphagia/ Odynophagia (1815); Pain (1994); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - 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 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, it has been determined that no corrective and 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 (b)(6) as follows: this report is being filed after the review of the following journal article: qiang s., et al (2016) anterior cervical discectomy and fusion versus anterior cervical corpectomy and fusion for treating two-level contiguous cervical spondylotic myelopathy, chinese journal of tissue engineering research.20, no.48, pages 7175-7184 (china).This prospective, randomized, contrastive clinical study aims to compare the differences in the surgical treatment of two-level csm between discectomy with stand-alone cage technique and corpectomy with plate-mesh technique.Between december 2006 and december 2009, a total of 80 patients with a consecutive sequence of hospitalization were randomized in a 1:1 ratio to an anterior cervical discectomy and fusion group (acdf group) and an anterior cervical corpectomy and fusion group (accf group).Of the original 80 patients 69 patients remained, 33 were in the acdf group (15 males, 18 females) with a mean age of 52.3 years (range: 27-67 years), and 36 were in the accf group (23 males,13 females) with a mean age of 55.8 years (range: 25-71 years).A total of 66 cages, including bengal (19 patients), depuy synthes spine, raynham, ma, usa; ao syncage (7 patients), synthes spine, west chester, pa, usa, and another competitors device were used in the acdf group.A total of 36 plate-meshes, including codman¿ (4 patients), codman & shurtleff, inc., raynham, ma, usa slim-loc" (3 patients), depuy synthes spine; skyline¿ (9 patients), depuy synthes spine; cslp-va (3 patients), synthes gmbh, oberdorf, switzerland and other competitors device were used in accf group.The follow-up period of the patients ranged from 62 to 98 months (average 83.6).The following complications were reported: acdf group: the loss of correction of segmental height was large.1 wound swelling.2 dysphagia.Both post-operative and 5-year follow-up segmental height was significantly larger than pre-operative segmental height.Instrument subsidence rates were 31%.Acff group: loss of correction of segmental height.1 wound swelling.1 dysphagia.Acute radicular pain.1 csf leakage.1 hoarseness.Only post-operative segmental height was significantly larger than pre-operative segmental height.Instrument subsidence rates were 13 %.This report is for an unknown depuy synthes spine ao syncage and unknown synthes cslp-va with mesh.This report is for (1) unk - screws.This report is 4 of 8 for (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11960890
• MDR Text Key: 267106618
• Report Number: 8030965-2021-04683
• Device Sequence Number: 1
• Product Code: HWC
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 05/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention