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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.439 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

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SYNTHES GMBH PSI SD800.439 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE Back to Search Results
Catalog Number SD800.439
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2021. 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in 2021 during an unknown procedure, the patient underwent surgery with the psi peek implants in question. After closing, post surgery germs were detected and a revision surgery was performed. There was no allegation against the device. The procedure was completed without surgical delay. This report is for one (1) psi sd800. 439 peek implant. This is report 1 of 2 for (b)(4).
 
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Brand NamePSI SD800.439 PEEK IMPLANT
Type of DevicePLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11385667
MDR Text Key243128945
Report Number8030965-2021-01399
Device Sequence Number1
Product Code GXN
UDI-Device Identifier07611819341371
UDI-Public(01)07611819341371
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K053199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSD800.439
Device Lot Number86P7078
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/26/2021 Patient Sequence Number: 1
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