MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN DYNESYS SPINE IMPL WIN GEN; SPINE PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that 1 patient underwent revision for extension of tether (adding on).Outcome- revision due to implant fracture.

Manufacturer Narrative

Journal received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Manufacturer Narrative

Journal received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that 1 patient underwent revision for extension of tether (adding on).Outcome- revision due to implant fracture.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: in the journal article anterior vertebral body tethering for treatment of idiopathic scoliosis in the skeletally immature one case required revision surgery for tether extension (adding on).Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Anterior vertebral body tethering for treatment of idiopathic scoliosis in the skeletally immature summary of the journal article anterior vertebral body tethering for treatment of idiopathic scoliosis in the skeletally immature: study design: prospective case series.Objective: determine the efficacy of anterior vertebral body tethering (avbt) in skeletally immature patients.Methods: consecutive skeletally immature patients with idiopathic scoliosis were treated with avbt between 2012 and 2018 by one of two surgeons working at two independent centers and followed up for >2 years.Data were collected prospectively and supplemented retrospectively where necessary.Outcomes were measured preoperatively, at first erect radiograph (fe), 1-year postoperatively and at most recent follow up (fu).Clinical success: of the 112 cases seven had undergone or were awaiting a fusion.Of the remaining cases 80 (71%) had tethered curve(s) <35° at fu and were considered successful.Complications and revisions: fifteen patients (13%) required 18 revision operations.Amongst the 18 revisions, one case required revision for tether extension (adding on).Results: one hundred twelve patients underwent 116 primary tethering procedures (108 thoracic and eight lumbar tethers).Twenty-five patients (22%) had 28 complications.Fifteen patients (13%) requiring 18 revision operations including six completed and one awaited fusions.Conclusion: avbt of immature cases is associated with satisfactory deformity correction in the majority of cases.However, complication and revision rates suggest the need for improved implants and patient selection.Product evaluation: no product was returned; therefore, visual evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Dhr review: review of the device history records could not be performed due to missing product identification.Conclusion: in the journal article anterior vertebral body tethering for treatment of idiopathic scoliosis in the skeletally immature one case required revision surgery for tether extension (adding on).The exact reason for the adding on is not described in the article and remains unknown.The dynesys spinal system (dynesys lis, dynesys top-loading system and zimmer dto system) is indicated to provide spinal alignment and dynamic re-stabilization in skeletally mature patients up to 5 contiguous levels from l1 to s1 (dynamic neutralization).Contraindications include scoliosis > 10° and treatment of the thoracic and cervical spine.Therefore, use in immature patients and/or patients with scoliosis greater than 10° is considered off-label use.The investigation did not identify a nonconformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Manufacturer Narrative

"this follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.".

Event Description

No additional information at the time of this report.

• Brand Name: UNKNOWN DYNESYS SPINE IMPL WIN GEN
• Type of Device: SPINE PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13556684
• MDR Text Key: 285989010
• Report Number: 0009613350-2022-00090
• Device Sequence Number: 1
• Product Code: NQP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• 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,Followup,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention