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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 4.5 MM NARROW LIMITED CONTACT LOCKING COMPRESSION PLATES (LC-LCP) PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: 4.5 MM NARROW LIMITED CONTACT LOCKING COMPRESSION PLATES (LC-LCP) PLATE, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This report is for an unk - screws: spine/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is a j&j representative. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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 (b)(6) 2021, the surgeon set the plate for the guiding block at the demonstration. After the demonstration, by using the drill sleeve to remove the plate from the guiding block, but the plate couldn't be removed from the guiding block. Finally, remove the guiding block about 30 minutes. No further information is available. This complaint involves three(3) devices. This report is for (1) unk - plates: 4. 5 mm narrow limited contact locking compression plates (lc-lcp) this report is 3 of 3 for (b)(4).

 
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Brand NameUNK - PLATES: 4.5 MM NARROW LIMITED CONTACT LOCKING COMPRESSION PLATES (LC-LCP)
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12367172
MDR Text Key268130367
Report Number8030965-2021-07200
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/28/2021
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?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/25/2021 Patient Sequence Number: 1
Treatment
GUIDINGBLOCK F/LOCKING ATTACHMENT PLATE.; LCP DRILL SLEEVE 3.5 F/DRILL BIT Ø2.8 03.
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