MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.501 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number SD800.501

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported on an unknown date that the surgeon noticed that an implant and verification model did not have the same thickness.It was unknown whether there was any patient involvement.There were no patient involvement.This complaint involves one (1) device.This report is for one (1) psi sd800.501 peek implant.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Event year is reported as 2022; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: g1: manufacture site updated.H3, h4, h6: investigation summary 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 history lot: part number: sd800.501-us, lot number: 2979p37, part manufacture date: 11-07-2022, manufacturing location: brandywine , part expiration date: n/a , nonconformance noted: n/a.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the peek implant was processed through the operations on the released routing for part number sd800.501 and had met all specification criteria at the time of release with no issues documented that would contribute to the complaint condition.Device history review : the product lot met all specification criteria at the time of release with no issues documented that would contribute to the complaint condition.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.B5: it is unknown if there was patient involvement.No additional information is available.

• Brand Name: PSI SD800.501 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES USA BRANDYWINE; 1301 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15936776
• MDR Text Key: 308085949
• Report Number: 8030965-2022-10784
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065618
• UDI-Public: (01)10887587065618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD800.501
• Device Catalogue Number: SD800.501
• Device Lot Number: 2979P37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1