MAUDE Adverse Event Report: ZIMMER GMBH DYNESYS SCREW SPINE; N/A

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional device information: unique identifier (udi) # n/a.Concomitant medical products and therapy date.Detail of product: item number: unknown; item name: dynesys cord spine impl win gen; lot # unknown.Item number: unknown; item name: dynesys spacer spine impl win gen; lot # unknown.As no lot number was provided, the device history records could not be reviewed.The manufacturer did not receive x-rays, or other source documents for review, neither the device has been received for investigation as the patient has not been revised.Additional information has been requested and is currently not available.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 patient started to be monitored following pain due to torn out / migrated screws.

Event Description

No event update.

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): as no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Review of event description: it was reported that a male patient had dynesys dynamic stabilization devices implanted some years before and experienced hip pain for the past year.It has finally been determined that the lowest right side cannulated screw, going into his hip is not where it should be.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.According to the available information, the product remains implanted.Root cause analysis: root cause determination rmw: implant migration due to mri interacts with titanium implant components.Possible, no medical data received to confirm, however, cannot be excluded.Conclusion summary: no ref/lot of the products were reported for the investigation.Compatibility of the implanted items is unknown.No medical documents were received to confirm the event.No patient/surgery info was available.In the absence of required information it is not possible to make a deep analysis of the event.Possible reasons for the migration of the device include mri interaction with titanium implant components or malpositioned implants during the primary surgery.Therefore, based on the given information and the results of the investigation, the complaint could not be confirmed and no specific root cause for this issue could be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: DYNESYS SCREW SPINE
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7973177
• MDR Text Key: 123941181
• Report Number: 0009613350-2018-01077
• Device Sequence Number: 1
• Product Code: NQP
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• 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: DYNESYS SCREW SPINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other