MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PRO-DENSE; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	87SR0100
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the prodense hardened too quickly and was not able to be injected into the patient.There was a backup solution from another company that was able to be used.
Event or Problem Description
It was reported that the prodense hardened too quickly and was not able to be injected into the patient.There was a backup solution from another company that was able to be used.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the product was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Successful use of the product requires the surgical team to accurately control mixing time, mixing speed, complete mixing, use of all components supplied, using only those components supplied in the kit (no substitution).Any variable outside the parameters supplied in the mixing instructions may affect the chemical and physical properties of the product.While these occurrences are rare, this is a known potential issue for this product.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The ifu clearly instructs the user that: "inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure.¿ if any further information is provided, the complaint report will be updated.

• Brand Name: PRO-DENSE
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 12237496
• Report Number: 0001043534-2021-00124
• Device Sequence Number: 19850225
• Product Code: MQV
• UDI-Device Identifier: 00889797072762
• UDI-Public: 00889797072762
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2025
• Device Model Number: 87SR0100
• Device Catalogue Number: 87SR0100
• Device Lot Number: 1696601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1